CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.

BACKGROUND: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year. OBJECTIVE: To evaluate angiographic stability at 1 year. METHODS: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design. RESULTS: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.

Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN.

BACKGROUND: Multiple studies and meta-analyses have described the technical and clinical outcomes in large cohorts of aneurysm patients treated with flow diverters (FDs). Variations in evaluation methodology complicate making comparisons among studies, hinder understanding of the device behavior, and pose an obstacle in the assessment of further advances in FD therapy. METHODS: A multidisciplinary panel of neurointerventionalists, imaging experts, and neuroradiologists convened with the goal of establishing consensus recommendations for the standardization of image analyses in FD studies. RESULTS: A standardized methodology is proposed for evaluating and reporting radiological outcomes of FD treatment of intracranial aneurysms. The recommendations include general imaging considerations for clinical studies and evaluations of longitudinal changes, such as neointimal lining and stenosis. They cover standards for classification of aneurysm location, morphology, measurements, as well as the assessment of aneurysm occlusion, wall apposition, and neck coverage. These reporting standards further define four specific braid deformation patterns: foreshortening, fish-mouthing, braid bump deformation, and braid collapse, collectively termed 'F2B2'. CONCLUSIONS: When widely applied, standardization of methods of measuring and reporting outcomes will help to harmonize the assessment of treatment outcomes in clinical studies, help facilitate communication of results among specialists, and help enable research and development to focus on specific aspects of FD techniques and technology.

Preclinical in vitro and in vivo results of the new silk vista flow diverter with P8RI coating.

BACKGROUND: Flow diverting stents (FDS) have transformed the treatment of intracranial aneurysms; however, their metallic structure associated with their intra-luminal positioning hamper angiographic and clinical outcomes. Therefore, there is a need to develop FDS with optimized surfaces that reduce thrombogenicity while promoting the healing process and endothelialization. METHODS: P8RI, a peptide mimicking the CD31 protein, was previously developed and grafted onto Silk Vista (SV) FDS. P8RI-SV and bare-SV were used in vitro in a blood loop model to test their hemocompatibility using human whole blood and in vivo using the rabbit elastase model for optical coherence tomography (OCT) comparisons of neointimal formation at day 5 and day 28. RESULTS: After blood loop incubation, P8RI-SV showed significant reduction in fibrin binding (p=0.004) and platelet adhesion (p=0.041) compared with bare-SV. Similarly, derivative markers measured in blood, thromboxane B2 (platelet activation) and Thrombin-Antithrombin III complexes (coagulation activation), were also significantly reduced in the P8RI-SV group (both p=0.002). In vivo, complete or near-complete occlusion was reached in all aneurysms (n=6) at day 28. Excellent rate of stent-coverage ratio was obtained at day 5 (89.3% (79.1%-98.7%)) comparable to the observation at day 28 (91.8% (79.1%-100%); p=0.44). These rates were significantly higher compared with bare-SV at day 5 (77.8% (58.3%-86.8%); p<0.001) and at day 28 (67.7% (52.6%-88.9%); p<0.0001). CONCLUSION: In vitro results confirm enhanced hemocompatibility with a significant anti-thrombotic effect of the P8RI-SV. In vivo results provide evidence of rapid neo-intimal growth reaching near-complete tissue healing as early as day 5 in a rabbit model.

Comparison of rescue intracranial stenting versus best medical treatment alone in acute refractory large vessel occlusion: study protocol for the PISTAR multicenter randomized trial.

BACKGROUND: Mechanical thrombectomy (MT) has become a standard treatment for acute ischemic strokes (AIS). However, MT failure occurs in approximately 10-30% of cases, leading to severe repercussions (with mortality rates up to 40% according to observational data). Among the available rescue techniques, rescue intracranial stenting (RIS) appears as a promising option. OBJECTIVE: This trial is poised to demonstrate the superiority of RIS in addition to the best medical treatment (BMT) in comparison with BMT alone, in improving the functional outcomes at 3 months for patients experiencing an AIS due to a large vessel occlusion refractory to MT (rLVO). METHODS: Permanent Intracranial STenting for Acute Refractory large vessel occlusions (PISTAR) is a multicenter prospective randomized open, blinded endpoint trial conducted across 11 French University hospitals. Adult patients (≥18 years) with an acute intracranial occlusion refractory to standard MT techniques will be randomized 1:1 during the procedure to receive either RIS+BMT (intervention arm) or BMT alone (control arm). RESULTS: The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin Scale score ≤2 and evaluated by an independent assessor blinded to the randomization arm. Secondary outcomes include hemorrhagic complications, all adverse events, and death. The number of patients to be included is 346. Two interim analyses are planned with predefined stopping rules. CONCLUSION: The PISTAR trial is the first randomized controlled trial focusing on the benefit of RIS in rLVOs. If positive, this study will open new insights into the management of AIS. TRIAL REGISTRATION NUMBER: NCT06071091.

Mechanical thrombectomy in basilar artery occlusions: impact of first-line strategy as a function of the occlusion level.

BACKGROUND: Retrospective studies suggest the superiority of first-line contact aspiration (CA) thrombectomy over stent-retriever (SR) in basilar artery occlusions (BAO). We aimed to investigate the impact of first-line mechanical thrombectomy per the occlusion level, considering differences in stroke etiology prevalence between proximal and distal BAO. METHODS: A retrospective, multicentric analysis of the Endovascular Treatment in Ischemic Stroke Registry (ETIS) included consecutive BAO patients treated from January 2016 to May 2022. Patients were categorized into SR (±aspiration) and CA alone groups. Occlusion levels were determined through digital subtraction angiography. Favorable clinical outcome was defined as 90-day modified Rankin Scale (mRS) 0-3. RESULTS: A total of 380 patients were analyzed (251 CA alone, 129 SR±aspiration). Globally, first-line SR showed lower recanalization rates (89.1% vs 94.8%, OR=0.29, 95% CI 0.16 to 0.53; p<0.001) and worse clinical outcomes (mRS 0-3: 46.0% vs 52.2%, OR=0.62, 95% CI 0.44 to 0.87; p=0.006) compared with CA. In proximal occlusions, SR was significantly associated with poorer clinical outcomes (mRS 0-3: 20.9% vs 37.1%; OR=0.40, 95% CI 0.19 to 0.83; p=0.014) despite similar recanalization rates. Conversely, in distal occlusions there was no difference in clinical outcomes although recanalization rates were higher with CA (modified Thrombolysis in Cerebral Infarction score (mTICI 2b/3): 97.7% vs 91.7%; OR=0.17, 95% CI 0.05 to 0.66; p=0.01). CONCLUSIONS: In our BAO population, CA demonstrated better angiographic outcomes in middle and distal occlusions and better clinical outcomes in proximal occlusions. This translated into better angiographic and clinical results in the global study population. Clinical results were particularly influenced by the negative impact of SR on 90-day mRS, independently of recanalization rates in proximal BAO.

Primary results from the CLEAR study of a novel stent retriever with drop zone technology.

BACKGROUND: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. OBJECTIVE: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. METHODS: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). RESULTS: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). CONCLUSIONS: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. TRIAL REGISTRATION NUMBER: NCT04514562.

CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms.

BACKGROUND: Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. METHODS: The CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months. RESULTS: A total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed. CONCLUSION: Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up. TRIAL REGISTRATION NUMBER: NCT03844334.

Determinants of cerebral aneurysm occlusion after embolization with the WEB device: a single-institution series of 215 cases with angiographic follow-up.

BACKGROUND: Woven EndoBridge (WEB) devices are becoming a reliable option for the treatment of wide-neck bifurcation aneurysms, but clear predictive factors are still missing to understand the one in five aneurysm remnant rate. OBJECTIVE: To evaluate occlusion outcomes after WEB treatment to identify potential determinants of aneurysm occlusion. METHODS: A single-center database with consecutive aneurysms treated with WEB between July 2012 and October 2021 was reviewed for potential determinants of aneurysm adequate occlusion (defined as a Bicêtre Occlusion Scale Score (BOSS) of 0, 0', 1 or 2), through univariate and multivariable analysis. Patients without angiographic follow-up were excluded. RESULTS: 215 of 247 individual aneurysms were included in the final analysis, of which 59 (27%) were ruptured. Mean age of patients was 56 years (range 23-90 years) and 65% were female. Mean angiographic follow-up was at 18 months (range 3-97 months). Adequate and complete occlusion were achieved in 171/215 (79.5%) and 135/215 (62.8%) of cases, respectively. Aneurysm irregular shape (aOR=0.42, 95% CI 0.20 to 0.88; p=0.02), aneurysm height (aOR=0.79, 95% CI 0.66 to 0.94; p<0.01), and WEB shape modification (aOR=0.98, 95% CI 0.97 to 1.00; p=0.02) were all independent predictors of aneurysm recurrence, whereas the WEB oversizing ratio (WEB width/aneurysm mean width) (aOR=16.4, 95% CI 1.4 to 266.7; p=0.04) was an independent predictor of adequate occlusion. CONCLUSION: In this study we demonstrated that a width oversizing strategy of the WEB device was an independent predictor of aneurysm angiographic occlusion. Conversely, aneurysm height, irregular aneurysm, and WEB shape modification were all independent determinants of angiographic aneurysm remnant. These results may help to select aneurysms suitable for the WEB device and WEB sizing.

Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up.

BACKGROUND: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used. RESULTS: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms). CONCLUSIONS: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%). CLINICAL TRIAL REGISTRATION: WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design.

BACKGROUND: Due to its high efficacy, flow diversion is increasingly used in the management of unruptured and recanalized aneurysms. Because of the need for perioperative dual antiplatelet treatment (DAPT), flow diversion is not indicated for the treatment of ruptured aneurysms. To overcome this major limitation, surface modification-'coating'-of flow diverters has been developed to reduce platelet aggregation on the implanted device, reduce thromboembolic complications, and facilitate the use of coated flow diverter treatment in patients with single antiplatelet treatment (SAPT). COATING (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) is a prospective, randomized, multicenter trial that aims to determine whether the use of the coated flow diverter p64 MW HPC under SAPT is non-inferior (or even superior) to the use of the bare flow diverter p64 MW under DAPT in relation to thromboembolic and hemorrhagic complications. METHODS: Patients with unruptured or recanalized aneurysms for which endovascular treatment with a flow diverter is indicated will be enrolled and randomly assigned on a 1:1 ratio to one of two treatment groups: p64 MW HPC with SAPT or p64 MW with DAPT. RESULTS: The primary endpoint is the number of diffusion-weighted imaging lesions visualized via MRI assessed within 48 hours (±24 hours) of the index procedure. Secondary primary endpoints are comparing safety and efficacy in both arms. CONCLUSIONS: This randomized controlled trial is the first to directly compare safety and efficacy of coated flow diverters under SAPT with bare flow diverters under DAPT. TRIAL REGISTRATION NUMBER: http://clinicaltrials.gov/ - NCT04870047.

Management of aneurysmal recurrence after Woven EndoBridge (WEB) treatment.

BACKGROUND: Around 10% of Woven EndoBridge device (WEB)-treated intracranial aneurysms will need retreatment, and it is generally believed to be more challenging than retreatment after an initial coiling. We aim to report retreatment strategies and outcomes after initial WEB embolizations. METHODS: Databases from four treatment centers, containing consecutive aneurysms treated with a WEB between 2013 and 2022, were reviewed. Demographics, aneurysm characteristics, retreatment strategies and outcomes were collected and analyzed. RESULTS: From a 756 WEB database, 57 aneurysms were included. The global retreatment rate was 7.5% (95% CI 5.6% to 9.4%). The retreatment rate was significantly higher in the ruptured compared with the unruptured population (13% vs 3.9%, respectively, P<0.0001). Aneurysms were retreated on average 21.2 months after the initial WEB treatment (range 4.8-70 months). Surgery was performed in 11% and endovascular treatment in 89% of cases, consisting of flow diversion (48%), stent-assisted coiling (30%), coiling (12%), and second WEB placement (10%). Imaging follow-up was available in 88% of all WEB retreatments (50/57) (average 17 months, 49% digital subtraction angiography), demonstrating complete occlusion in 56% and 'adequate' occlusion in 88%. Morbidity was 5.3% (95% CI 0% to 12.0%) and mortality 0%. No patient experienced rebleeding during the follow-up period. CONCLUSION: The retreatment rate after an initial WEB treatment seems to compare favorably with that of coiling. Endovascular treatment of recurrence following WEB implantation is feasible in most situations; it generally requires the use of a stent and leads to a high rate of satisfactory occlusion.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study.

BACKGROUND: The CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study. METHODS: The CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients with 60 ruptured aneurysms of the anterior and posterior circulation. The study was conducted with an independent assessment of safety outcomes and imaging. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. Fifty-three aneurysms (88.3%) had a broad base with a dome to neck ratio <2 (mean 1.6). Of these, 46 patients were evaluated by an independent core laboratory with follow-up imaging performed at 12 months or before eventual retreatment. At 1 year, 19/46 aneurysms (41.3%) were completely occluded (Raymond-Roy grade I), 21/46 (45.7%) had a residual neck and 6/46 (13.0%) had residual aneurysm filling. Adequate occlusion was reported in 40/46 (87%) aneurysms. Six patients underwent target aneurysm retreatment. CONCLUSIONS: The CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms.

Woven EndoBridge device shape modification can be mitigated with an appropriate oversizing strategy: a VasoCT based study.

BACKGROUND: The Woven EndoBridge (WEB) shape modification (WShM) during follow-up may be a potential cause of poor angiographic outcomes. WShM predisposing factors have not yet been determined. Our systematic use of rotational cone beam computed tomography (VasoCT) imaging during follow-up allowed us to perform the first quantitative analysis of the shape of WEBs over time. Our goal was to identify possible strategies to reduce the occurrence of this phenomenon. METHODS: All patients treated in our hospital with a WEB device between October 2015 and January 2019 were included. Using VasoCT acquisitions, systematically performed after implantation and during follow-up, we analyzed WEB morphology. WShM was defined as the percentage reduction in the distance between the two WEB markers. RESULTS: Sixty-three aneurysms treated with a WEB device were finally included in this analysis. At the last follow-up (mean 15.5 months), mean WShM was 48%±24. The mean WShM was significantly higher in the aneurysm recurrence group than in the adequate occlusion group (51±6.5% vs 36±3.4%, difference 15% points (95% CI 0.7 to 30); p<0.05). Conversely, the extent of WShM did not directly correlate with occlusion rates. Indeed, 32% of completely occluded aneurysms presented severe WShM (≥50%). Importantly, the absence of WShM guaranteed complete occlusion in our study (n=12). We demonstrated that oversizing the width of the WEB significantly correlated with WShM reduction during follow-up (r=-0.38, p=0.002). CONCLUSION: WShM can be partly overcome by use of an appropriate width oversizing strategy that could lead to improved angiographic results.

WEB device for treatment of posterior communicating artery aneurysms.

BACKGROUND: Woven EndoBridge (WEB) device treatment of wide-neck bifurcation aneurysms has proved to be safe and effective, but the use of these devices in sidewall aneurysms has been reported only in a small number of case series. OBJECTIVE: To report our results in a cohort of consecutive patients in whom a WEB device was used as first-line treatment for posterior communicating artery (PComA) aneurysms. METHODS: We conducted a retrospective analysis of a prospectively maintained database of PComA aneurysms treated with a WEB device in our institution from June 1, 2012 to November 15, 2020. Clinical and radiological findings were evaluated at immediate and last follow-up. RESULTS: A total of 219 aneurysms were treated with a WEB device, including 15 PComA aneurysms in 15 patients, 10 of which were ruptured. Aneurysms were wide necked, with a mean aspect ratio of 1.6 (range 0.7-3.0) and a mean neck size of 4.2 mm (range 2.6-7.4 mm). No intraoperative rupture occurred and only one thromboembolic event was noted. Among the group with at least a 3-month digital subtraction angiography (DSA) follow-up, complete and adequate occlusion were obtained in 54% and 72%, respectively (average follow-up 13 months). Re-treatment was needed for two initially ruptured aneurysms. No procedure-related morbidity or mortality was reported. CONCLUSION: This series suggests the high safety profile of WEB devices even when used in off-label indications. Treatment with these devices seems to be a valuable strategy for ruptured wide-neck PComA aneurysms, avoiding the need for antiplatelet medication. However, occlusion rates should be investigated in further larger studies.

Patient and aneurysm factors associated with aneurysm recanalization after coiling.

BACKGROUND: One limitation of the endovascular treatment of intracranial aneurysms is aneurysm recanalization. The Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) study is a prospective multicenter cohort study evaluating the factors associated with recanalization after endovascular treatment. METHODS: The current analysis is focused on patients treated by coiling or balloon-assisted coiling (BAC). Postoperative, mid-term vascular imaging, and evolution of aneurysm occlusion were independently evaluated by two neuroradiologists. A 3-grade scale was used for aneurysm occlusion (complete occlusion, neck remnant, and aneurysm remnant) and for occlusion evolution (improved, stable, and worsened). Recanalization was defined as any worsening of aneurysm occlusion. RESULTS: Between December 2013 and May 2015, 16 French neurointerventional departments enrolled 1289 patients. A total of 945 aneurysms in 908 patients were treated with coiling or BAC. The overall rate of aneurysm recanalization at mid-term follow-up was 29.5% (95% CI 26.6% to 32.4%): 28.9% and 30.3% in the coiling and BAC groups, respectively. In multivariate analyses factors independently associated with recanalization were current smoking (36.6% in current smokers vs 24.5% in current non-smokers (OR 1.8 (95% CI 1.3 to 2.4); p=0.0001), ruptured status (31.9% in ruptured aneurysms vs 25.1% in unruptured (OR 1.5 (95% CI 1.1 to 2.1); p=0.006), aneurysm size ≥10 mm (48.8% vs 26.5% in aneurysms <10 mm (OR 2.6 (95% CI 1.8 to 3.9); p<0.0001), wide neck (32.1% vs 25.8% in narrow neck (OR 1.5 (95% CI 1.1 to 2.1); p=0.02), and MCA location (34.3% vs 28.3% in other locations (OR 1.5 (95% CI 1.0 to 2.1); p=0.04). CONCLUSIONS: Several factors are identified by the ARETA study as playing a role in aneurysm recanalization after coiling: current smoking, aneurysm status (ruptured), aneurysm size (≥10 mm), neck size (wide neck), and aneurysm location (middle cerebral artery). This finding has important consequences in clinical practice. TRIAL REGISTRATION NUMBER: URL: http://www. CLINICALTRIALS: gov; Unique Identifier: NCT01942512.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study.

BACKGROUND: The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. METHODS: The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. CONCLUSIONS: The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.

Collateral status reperfusion and outcomes after endovascular therapy: insight from the Endovascular Treatment in Ischemic Stroke (ETIS) Registry.

BACKGROUND: Studies have suggested that collateral status modifies the effect of successful reperfusion on functional outcome after endovascular therapy (EVT). We aimed to assess the association between collateral status and EVT outcomes and to investigate whether collateral status modified the effect of successful reperfusion on EVT outcomes. METHODS: We used data from the ongoing, prospective, multicenter Endovascular Treatment in Ischemic Stroke (ETIS) Registry. Collaterals were graded according to the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) guidelines. Patients were divided into two groups based on angiographic collateral status: poor (grade 0-2) versus good (grade 3-4) collaterals. RESULTS: Among 2020 patients included in the study, 959 (47%) had good collaterals. Good collaterals were associated with favorable outcome (90-day modified Rankin Scale (mRS) 0-2) (OR 1.5, 95% CI 1.19 to 1.88). Probability of good outcome decreased with increased time from onset to reperfusion in both good and poor collateral groups. Successful reperfusion was associated with higher odds of favorable outcome in good collaterals (OR 6.01, 95% CI 3.27 to 11.04) and poor collaterals (OR 5.65, 95% CI 3.32 to 9.63) with no significant interaction. Similarly, successful reperfusion was associated with higher odds of excellent outcome (90-day mRS 0-1) and lower odds of mortality in both groups with no significant interaction. The benefit of successful reperfusion decreased with time from onset in both groups, but the curve was steeper in the poor collateral group. CONCLUSIONS: Collateral status predicted functional outcome after EVT. However, collateral status on the pretreatment angiogram did not decrease the clinical benefit of successful reperfusion.

Endovascular reperfusion of M2 occlusions in acute ischemic stroke reduced disability and mortality: ETIS Registry results.

BACKGROUND: The predictors of successful reperfusion and the effect of reperfusion after endovascular treatment (EVT) for M2 occlusions have not been well studied. We aimed to identify predictors of successful reperfusion and the effect of reperfusion on outcomes of EVT for M2 occlusions in current practice. METHODS: Patients with acute ischemic stroke due to isolated M2 occlusions who were enrolled in the prospective multicenter Endovascular Treatment in Ischemic Stroke (ETIS) Registry in France between January 2015 and March 2020 were included. The primary outcome was a favorable outcome, defined as modified Rankin Scale (mRS) score of 0-2 at 90 days. Successful reperfusion was defined as an improvement of ≥1 points in the modified Thrombolysis In Cerebral Infarction score between the first and the last intracranial angiogram. RESULTS: A total of 458 patients were included (median National Institutes of Health Stroke Scale (NIHSS) score 14; 61.4% received prior intravenous thrombolysis). Compared with the non-reperfused patients, reperfused patients had an increased rate of excellent outcome (OR 2.3, 95% CI 0.98 to 5.36; p=0.053), favorable outcome (OR 2.79, 95% CI 1.31 to 5.93; p=0.007), and reduced 90-day mortality (OR 0.39, 95% CI 0.19 to 0.79; p<0.01). Admission NIHSS score was the only predictor of successful reperfusion. First-line strategy was not a predictor of successful reperfusion or favorable outcome, but the use of a stent retriever, alone or with an aspiration catheter, was associated with higher rates of procedural complications and 90-day mortality. CONCLUSIONS: Successful reperfusion of M2 occlusions reduced disability and mortality. However, safety is a concern, especially if the procedure failed.

Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device.

BACKGROUND: The use of flow diversion to treat intracranial aneurysms has increased in recent years. OBJECTIVE: To assess the safety and angiographic efficacy of the p64 flow modulation device. METHODS: Diversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography. RESULTS: A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10). CONCLUSIONS: Diversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.