Prasugrel Single Antiplatelet Therapy versus Aspirin and Clopidogrel Dual Antiplatelet Therapy for Flow Diverter Treatment for Cerebral Aneurysms: A Retrospective Multicenter Study.

BACKGROUND AND PURPOSE: The optimal antiplatelet regimen after flow diverter treatment of cerebral aneurysms is still a matter of debate. A single antiplatelet therapy might be advantageous in determined clinical scenarios. This study evaluated the efficacy and safety of prasugrel single antiplatelet therapy versus aspirin and clopidogrel dual antiplatelet therapy. MATERIALS AND METHODS: We performed a post hoc analysis of 4 retrospective multicenter studies including ruptured and unruptured aneurysms treated with flow diversion using either prasugrel single antiplatelet therapy or dual antiplatelet therapy. Primary end points were the occurrence of any kind of procedure- or device-related thromboembolic complications and complete aneurysm occlusion at the latest radiologic follow-up (mean, 18 months). Dichotomized comparisons of outcomes were performed between single antiplatelet therapy and dual antiplatelet therapy. Additionally, the influence of various patient- and aneurysm-related variables on the occurrence of thromboembolic complications was investigated using multivariable backward logistic regression. RESULTS: A total of 222 patients with 251 aneurysms were included, 90 (40.5%) in the single antiplatelet therapy and 132 (59.5%) in the dual antiplatelet therapy group. The primary outcome-procedure- or device-related thromboembolic complications-occurred in 6 patients (6.6%) of the single antiplatelet therapy and in 12 patients (9.0%) of the dual antiplatelet therapy group (P = .62; OR, 0.712; 95% CI, 0.260-1.930). The primary treatment efficacy end point was reached in 82 patients (80.4%) of the single antiplatelet therapy and in 115 patients (78.2%) of the dual antiplatelet therapy group (P = .752; OR, 1.141; 95% CI, 0.599-2.101). Logistic regression showed that non-surface-modified flow diverters (P = .014) and fusiform aneurysm morphology (P = .004) significantly increased the probability of thromboembolic complications. CONCLUSIONS: Prasugrel single antiplatelet therapy after flow diverter treatment may be as safe and effective as dual antiplatelet therapy and could, therefore, be a valid alternative in selected patients. Further prospective comparative studies are required to validate our findings.

Go Green in Neuroradiology: towards reducing the environmental impact of its practice.

Raising public awareness about the relevance of supporting sustainable practices is required owing to the phenomena of global warming caused by the rising production of greenhouse gases. The healthcare sector generates a relevant proportion of the total carbon emissions in developed countries, and radiology is estimated to be a major contributor to this carbon footprint. Neuroradiology markedly contributes to this negative environmental effect, as this radiological subspecialty generates a high proportion of diagnostic and interventional imaging procedures, the majority of them requiring high energy-intensive equipment. Therefore, neuroradiologists and neuroradiological departments are especially responsible for implementing decisions and initiatives able to reduce the unfavourable environmental effects of their activities, by focusing on four strategic pillars-reducing energy, water, and helium use; properly recycling and/or disposing of waste and residues (including contrast media); encouraging environmentally friendly behaviour; and reducing the effects of ionizing radiation on the environment. The purpose of this article is to alert neuroradiologists about their environmental responsibilities and to analyse the most productive strategic axes, goals, and lines of action that contribute to reducing the environmental impact associated with their professional activities.

Braid stability after flow diverter treatment of intracranial aneurysms: a systematic review and meta-analysis.

BACKGROUND: The aim of this study was to evaluate the overall rates of braid changes associated with flow diverter (FD) treatment for intracranial aneurysms (IAs). Additionally, we sought to provide an overview of the currently reported definitions related to these complications. METHODS: A systematic search was conducted from the inception of relevant literature up to April 2023, encompassing six databases. The included studies focused on patients with IAs treated with FDs. We considered four main outcome measures as FD braid changes: (1) fish-mouthing, (2) device braid narrowing, (3) device braid collapsing, and (4) device braid deformation. The data from these studies were pooled using a random-effects model. RESULTS: A total of 48 studies involving 3572 patients were included in the analysis. Among them, 14 studies (39%) provided definitions for fish-mouthing. However, none of the included studies offered specific definitions for device braid narrowing, collapsing, or deformation, despite reporting rates for these complications in six, five, and three studies, respectively. The pooled rates for braid changes were as follows: 3% (95% CI 2% to 4%, I2=27%) for fish-mouthing, 7% (95% CI 2% to 20%, I2=85%) for narrowing, 1% (95% CI 0% to 3%, I2=0%) for collapsing, and 1% (95% CI 1% to 4%, I2=0%) for deformation. CONCLUSION: The findings of this study suggest that FD treatment for IAs generally exhibits low rates of fish-mouthing, device braid narrowing, collapsing, and deformation. However, the lack of standardized definitions hinders the ability to compare device outcomes objectively, emphasizing the need for uniform definitions for FD braid changes in future prospective studies on FD.

Safety and Efficacy of Flow Diverters for Treatment of Unruptured Anterior Communicating Artery Aneurysms: Retrospective Multicenter Study.

BACKGROUND: The anterior communicating artery (AComm) region is the most common site of intracranial aneurysms, with increased rupture risk compared with other locations. Overall, flow diverters present as a safe and efficacious treatment for intracranial aneurysms, but there is paucity of data for their use in the treatment of unruptured AComm aneurysms. We present the largest multicentric analysis evaluating the outcomes of flow diverters in AComm aneurysm treatment. METHODS: Databases from 10 centers were retrospectively reviewed for unruptured AComm aneurysms treated with flow diverters. Demographics, clinical presentation, radiographic characteristics, procedural complications, and outcomes were assessed. RESULTS: A total of 144 patients harboring 147 AComm aneurysms were treated between January 2012 and December 2021. Seventy-four were women (51.4%) and median age was 60 (IQR 50-67) years. All were unruptured AComm aneurysms. Half of the cohort had similar anterior cerebral artery sizes (51.4%). The most common morphology was saccular (94.6%), with a branch involvement in 32.7% of cases. Median vessel diameter was 2.4 mm, and the Pipeline Flex was the most prevalent device (32.7%). Median follow-up time was 17 months, with complete occlusion in 86.4% at the last follow-up. Functional independence (modified Rankin Scale score 0-2) was reported in 95.1%. Intraprocedural complications occurred in 5.6%, and postoperative complications were noted in 9.7% of cases. Combined major complication and mortality rate was 2.1%. CONCLUSIONS: Our study suggests that flow diverters are a useful treatment for AComm aneurysms. Mid-term results indicated favorable aneurysm occlusion with a good safety profile. Additional prospective studies with longer follow-up periods and independent adjudication are warranted to better assess these results.

History of Neurointervention.

In this review article, we aim to provide a summary of the discoveries and developments that were instrumental in the evolution of the Neurointerventional field. We begin with developments in the advent of Diagnostic Cerebral Angiography and progress to cerebral aneurysm treatment, embolization in AVMs and ischemic stroke treatment. In the process we discuss many persons who were key in the development and maturation of the field. A pivotal aspect to rapid growth in the field has been the multidisciplinary involvement of the different neuroscience specialties and therefore we close out our discussion with excitement about ongoing and future developments in the field with a focus on treatments in the non-cerebrovascular disease realm.

Assessment of influence of facemask treatment with skeletal anchorage on the temporomandibular joint using magnetic resonance imaging: a preliminary study.

OBJECTIVE: The aim of the study was to investigate the influence of facemask treatment with skeletal anchorage on the temporomandibular joint (TMJ) using magnetic resonance imaging (MRI), in patients with Class III malocclusion, accompanied by maxillary retrusion. METHODS: Fifteen patients with a mean age of 12.1±1.43 years were included in the study. All patients were treated using facemask with skeletal anchorage after eight weeks of Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol. Magnetic resonance imaging was performed before and immediately after facemask treatment for TMJ evaluation. Disc position, condylar translation, degenerative changes of the condyles, and joint effusion were evaluated. To assess whether the alterations associated with the treatment were statistically significant, McNemar and marginal homogeneity tests were used. RESULTS: After facemask treatment, a statistically significant change was observed in the disc position (an anterior disc displacement with/without reduction in five TMJs) (p<0.05). The alteration in the condylar translation was not statistically significant (p>0.05). This treatment did not cause degenerative changes of the condyles or effusion in any of the TMJs. CONCLUSION: Facemask treatment with skeletal anchorage following the Alt-RAMEC protocol had a minimal influence on the TMJ, only by means of disc position, which was not negligible. Long-term results of such treatment are required for following up the changes observed in the TMJs.

Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular Therapy study (WEB-IT).

INTRODUCTION: The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients. METHODS: 150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator. RESULTS: 83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade. CONCLUSIONS: Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time.

First clinical multicenter experience with the new Pipeline Vantage flow diverter.

BACKGROUND: Flow diversion is an innovative and increasingly used technique for the treatment of intracranial aneurysms. New flow diverters (FDs) are being introduced to improve the safety and efficacy of this treatment. The aim of this study was to assess the safety, feasibility, and efficacy of the new Pipeline Vantage (PV) FD. METHODS: Patients with intracranial aneurysms treated with the PV at 10 international neurovascular centers were retrospectively analyzed. Patient and aneurysm characteristics, procedural parameters, complications, and the grade of occlusion were assessed. RESULTS: 60 patients with 70 aneurysms (5.0% with acute hemorrhage, 90.0% located in the anterior circulation) were included. 82 PVs were implanted in 61 treatment sessions. The PV could be successfully implanted in all treatments. Additional coiling was performed in 18.6%, and in-stent balloon angioplasty (to enhance the vessel wall apposition) in 24.6%. Periprocedural technical complications occurred in 24.6% of the treatments, were predominantly FD deployment problems, and were all asymptomatic. The overall symptomatic complication rate was 8.2% and the neurological symptomatic complication rate was 3.3%. Only one symptomatic complication was device-related (perforator artery infarctions leading to stroke). After a mean follow-up of 7.1 months, the rate of complete aneurysm occlusion was 77.9%. One patient (1.7%) died due to aneurysmal subarachnoid hemorrhage which occurred before treatment, unrelated to the procedure. CONCLUSIONS: The new PV FD is safe and feasible for the treatment of intracranial aneurysms. The short-term occlusion rates are promising but need further assessment in prospective long-term follow-up studies.

Republished: Multiplug flow control technique as a novel transarterial curative approach for the endovascular treatment of cerebrovascular malformations.

Herein, we describe the use of a novel multiplug flow control technique for the curative transarterial embolisation of cerebrovascular malformations using liquid embolic agents (LEAs). The idea behind the use of this technique is to substantially control or arrest flow during LEA injection, with multiple plugs simultaneously formed from microcatheters that are placed within all or multiple feeders, so that the penetration of LEAs is facilitated, with flow control decreasing the washout of a malformation. This technique enables the complete occlusion of a vascular malformation in a shorter injection time than that in other methods because penetration is achieved faster. Details of this technique have been described in the treatment of two cases: one case of unruptured temporal arteriovenous malformation and in the other with a falcotentorial dural arteriovenous fistula, in which the vascular malformations were successfully occluded with transarterial embolisation.

Assessment of influence of facemask treatment with skeletal anchorage on the temporomandibular joint using magnetic resonance imaging: a preliminary study

ABSTRACT Objective: The aim of the study was to investigate the influence of facemask treatment with skeletal anchorage on the temporomandibular joint (TMJ) using magnetic resonance imaging (MRI), in patients with Class III malocclusion, accompanied by maxillary retrusion. Methods: Fifteen patients with a mean age of 12.1±1.43 years were included in the study. All patients were treated using facemask with skeletal anchorage after eight weeks of Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol. Magnetic resonance imaging was performed before and immediately after facemask treatment for TMJ evaluation. Disc position, condylar translation, degenerative changes of the condyles, and joint effusion were evaluated. To assess whether the alterations associated with the treatment were statistically significant, McNemar and marginal homogeneity tests were used. Results: After facemask treatment, a statistically significant change was observed in the disc position (an anterior disc displacement with/without reduction in five TMJs) (p<0.05). The alteration in the condylar translation was not statistically significant (p>0.05). This treatment did not cause degenerative changes of the condyles or effusion in any of the TMJs. Conclusion: Facemask treatment with skeletal anchorage following the Alt-RAMEC protocol had a minimal influence on the TMJ, only by means of disc position, which was not negligible. Long-term results of such treatment are required for following up the changes observed in the TMJs.

RESUMO Objetivo: O objetivo desse estudo foi investigar a influência do tratamento com máscara facial com ancoragem esquelética na articulação temporomandibular (ATM), por meio de ressonância magnética (RM), em pacientes com má oclusão de Classe III acompanhada de retrusão maxilar. Métodos: Quinze pacientes com idade média de 12,1±1,43 anos foram incluídos no estudo. Todos os pacientes foram tratados com máscara facial com ancoragem esquelética após oito semanas de protocolo de Expansão Rápida da Maxila e Constrição Alternadas (Alt-RAMEC). Os exames de ressonância magnética foram realizados antes e imediatamente após o tratamento com máscara facial, para avaliação da ATM. Foram avaliados posição do disco, translação condilar, alterações degenerativas dos côndilos e derrame articular. Os testes de McNemar e de homogeneidade marginal foram utilizados para avaliar se as alterações associadas ao tratamento foram estatisticamente significativas. Resultados: Após o tratamento com máscara facial, uma mudança estatisticamente significativa foi observada na posição do disco (deslocamento anterior do disco com/sem redução em cinco ATMs) (p<0,05). A alteração na translação condilar não foi estatisticamente significativa (p>0,05). Esse tratamento não causou alterações degenerativas dos côndilos ou derrame em qualquer das ATMs. Conclusão: O tratamento com máscara facial com ancoragem esquelética ápós o protocolo Alt-RAMEC teve uma influência mínima na ATM, apenas quanto à posição do disco, que não foi desprezível. Resultados em longo prazo desse tratamento são necessários para acompanhar as mudanças observadas nas ATMs.

Women in neurointervention, a gender gap? Results of a prospective online survey.

BACKGROUND AND PURPOSE: Women's representation in medicine has increased over time yet the proportion of women practicing neurointervention remains low. We conducted an anonymous online survey through which we could explore the gender gap in neurointervention, identify potential issues, difficulties, or obstacles women might face, and evaluate if men encounter similar issues. METHODS: An online questionnaire was designed in SurveyMonkey®. Invitation to participate was emailed through national and international neurointerventional societies as well as directly through private mailing lists to men and women working in neurointervention. Responses were collected from 10 May 2019 to 10 September 2019. RESULTS: There were 295 complete responses, 173 (59%) male and 122 (41%) female. Most respondents (83%) fell within age categories 35-60 years, with representation from 40 countries across five continents. In all 95% were working full time, 73% had worked as a neurointerventionalist for >6 years, 77% worked in University-affiliated teaching institutions. Almost half of the respondents indicated no female neurointerventionalist worked in their center. Female respondents were younger and age-adjusted analysis was undertaken. Significantly fewer females than males were married and had children. Significantly fewer females held supervisory roles, held academic titles, and significantly less had a mentor. Females were less satisfied in their careers. More females felt they receive less recognition than colleagues of the opposite sex. Males had a greater proportion of work time dedicated to neurointervention. Similar proportions of both genders experienced bullying in work (40%-47%); however, sexual harassment was more common for females. There were no differences between genders in how they dealt with complications or their effects on mental well-being. CONCLUSION: There are many potential reasons why women are underrepresented in neurointervention, however, the literature suggests this is not unique to our specialty. Multiple long-term strategies will be necessary to address these issues, some of which are discussed in the article.

Safety and Efficacy of the FRED Jr Flow Re-Direction Endoluminal Device for Intracranial Aneurysms: Retrospective Multicenter Experience With Emphasis on Midterm Results.

Background and Purpose: Flow diversion is increasingly used as an endovascular treatment for intracranial aneurysms. In this retrospective multicenter study, we analyzed the safety and efficacy of the treatment of intracranial, unruptured, or previously treated but recanalized aneurysms using Flow Re-Direction Endoluminal Device (FRED) Jr with emphasis on midterm results. Materials and Methods: Clinical and radiological records of 150 patients harboring 159 aneurysms treated with FRED Jr at six centers between October 2014 and February 2020 were reviewed and consecutively included. Clinical outcome was measured by using the modified Rankin Scale (mRS). Anatomical results were assessed according to the O'Kelly-Marotta (OKM) scale and the Cekirge-Saatci Classification (CSC) scale. Results: The overall complication rate was 24/159 (16%). Thrombotic-ischemic events occurred in 18/159 treatments (11%). These resulted in long-term neurological sequelae in two patients (1%) with worsening from pre-treatment mRS 0-2 and mRS 4 after treatment. Complete or near-complete occlusion of the treated aneurysm according to the OKM scale was reached in 54% (85/158) at 6-month, in 68% (90/133) at 1-year, and in 83% (77/93) at 2-year follow-up, respectively. The rates of narrowing or occlusion of a vessel branch originating from the treated aneurysm according to the CSC scale were 11% (12/108) at 6-month, 20% (17/87) at 1-year, and 23% (13/57) at 2-year follow-up, respectively, with all cases being asymptomatic. Conclusions: In this retrospective multicenter study, FRED Jr was safe and effective in the midterm occlusion of cerebral aneurysms. Most importantly, it was associated with a high rate of good clinical outcome.

Multiplug flow control technique as a novel transarterial curative approach for the endovascular treatment of cerebrovascular malformations.

Herein, we describe the use of a novel multiplug flow control technique for the curative transarterial embolisation of cerebrovascular malformations using liquid embolic agents (LEAs). The idea behind the use of this technique is to substantially control or arrest flow during LEA injection, with multiple plugs simultaneously formed from microcatheters that are placed within all or multiple feeders, so that the penetration of LEAs is facilitated, with flow control decreasing the washout of a malformation. This technique enables the complete occlusion of a vascular malformation in a shorter injection time than that in other methods because penetration is achieved faster. Details of this technique have been described in the treatment of two cases: one case of unruptured temporal arteriovenous malformation and in the other with a falcotentorial dural arteriovenous fistula, in which the vascular malformations were successfully occluded with transarterial embolisation.

Long-term clinical and angiographic follow-up results of the dual-layer flow diverter device (FRED) for the treatment of intracranial aneurysms in a multicenter study.

PURPOSE: Our aim was to determine the long-term safety and efficacy of the Flow Re-Direction Endoluminal Device (FRED) in this multicenter study with prospective design. MATERIALS-METHOD: This study included 136 consecutive patients with 155 aneurysms treated between March 2013 and June 2016 in 10 centers. Twenty-two (16.2%) patients presented with rupture of the index aneurysm. Large/giant aneurysms comprised 1/3 of the cohort. Adjuvant coil use during the treatment was 15.5%. The effectiveness measure in the study was the percentage of aneurysms with stable occlusion at follow-up. RESULTS: Vascular imaging follow-up was performed at least once in 131/136 (96.3%) patients with 148/155 (95.5%) aneurysms up to 75 months (mean: 37.3 months; median: 36 months according to latest follow-up), and 102/155(65.8%) aneurysms in 90/136 (66.2%) patients had ≥ 24-month control. According to the latest controls, the overall stable occlusion rate was 91.9% (95% CI, 87.5 to 96.3%). Three out of 148 aneurysms with follow-up were retreated (2%, 95% CI 0.0 to 4.3%). Adverse events were noted in 19/136 (14%, 95% CI, 9 to 21%) patients with a morbidity of 1.5% (95% CI, 0.0 to 3.5%). Mortality was 1/136 (0.7%, 95% CI, 0.02 to 2.2%) and was unrelated to aneurysm treatment. In-stent stenosis (ISS) was detected in 10/131 of the patients with follow-up (7.6%, 95% CI; 3.1 to 12.2%), only one being symptomatic. No adverse events have occurred in any of the patients with follow-up after 24 months, except the one resulting from ISS. CONCLUSION: In the treatment of cerebral aneurysms which were candidates for flow diversion technique, this study showed long-term efficacy of FRED with good safety and occlusion rates.

First clinical multicenter experience with the new Scepter Mini microballoon catheter.

BACKGROUND: Balloon-assisted techniques can improve the endovascular treatment of cerebrospinal vascular malformations. The aim of this study was to report the first clinical multicenter experience with the new Scepter Mini dual-lumen microballoon catheter. METHODS: Patients with cerebral or spinal vascular malformations treated with the Scepter Mini at seven European neurovascular centers were retrospectively reviewed. Clinical data, angiographic features of the vascular malformations, procedural parameters including the type of application, navigability, technical failures, complications and embolization success were assessed. RESULTS: The usage of 34 Scepter Mini microballoon catheters in 20 patients was analyzed. Most treated malformations (80.0%) were cerebral arteriovenous malformations. Four different applications were reported: embolization via Scepter Mini (n=23, 67.6%), balloon-occlusion with simultaneous embolization via a second microcatheter (n=3, 8.8%), diagnostic angiography with simultaneous balloon-inflation for flow arrest (n=4, 11.8%), and navigation support (n=4, 11.8%). The mean diameter of the blood vessels in which the Scepter Mini was inflated was 1.9±0.5 mm. The navigability of the Scepter Mini was rated as 'easy' or 'very easy' in 88.2% of cases. Complete occlusion of the malformation was achieved in 60.9% of cases. Technical failures occurred in 4/23 embolization procedures, and all were related to insufficient stability of the balloon within the vessel. No complications related to the Scepter Mini were observed, while unrelated complications occurred in three patients (15.0%). CONCLUSIONS: The Scepter Mini is a promising new device for balloon-assisted embolization of cerebrospinal vascular malformations via small feeders. Beyond embolization, the Scepter Mini can also be used for other applications, such as superselective flow arrest and navigation support.

How to WEB: a practical review of methodology for the use of the Woven EndoBridge.

Wide-necked bifurcation aneurysms (WNBAs) make up 26-36% of all brain aneurysms. Treatments for WNBAs pose unique challenges due to the need to preserve major bifurcation vessels while achieving a durable occlusion of the aneurysm. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this review article we discuss various aspects of treating WNBAs with the WEB device, including indications for use, aneurysm/device selection strategies, antiplatelet therapy requirement, procedural technique, potential complications and bailouts, and management strategies for residual/recurrent aneurysms after initial WEB treatment.

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study.

INTRODUCTION: The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. METHODS: One-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety. RESULTS: One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study-a delayed ipsilateral parenchymal hemorrhage-on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects. CONCLUSIONS: The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer. TRIAL REGISTRATION NUMBER: NCT02191618.