[Advanced Setup and Techniques for Endovascular Treatment of Ruptured Intracranial Aneurysms].

Despite advancements in neurosurgical techniques, subarachnoid hemorrhage(SAH) caused by the rupture of a partially thrombosed intracranial giant aneurysm remains a challenging clinical entity. This report describes the successful treatment of an 80-year-old male patient with SAH due to a ruptured, partially thrombosed intracranial giant aneurysm. The patient underwent a staged endovascular strategy using a flow diverter. The patient presented with SAH secondary to a ruptured, partially thrombosed intracranial giant aneurysm located at the C2 portion of the internal carotid artery and involving the origin of the posterior communicating artery(Pcom). Imaging revealed a dorsomedial rupture point on the aneurysm. A two-stage endovascular intervention(IVR) was performed. The first stage involved coil embolization aimed at covering the rupture point. Following the resolution of the vasospasm and the acute phase of SAH, the second stage involved the deployment of a pipeline embolization device. Digital subtraction angiography performed one month after the second stage IVR demonstrated a significant reduction in aneurysm filling, with preserved flow to the Pcom artery. We will discuss the technical details and rationale behind the staged endovascular approach in this complex case.

PulseRider-assisted coil embolization for an unruptured internal carotid artery-persistent primitive trigeminal artery aneurysm.

A persistent primitive trigeminal artery (PPTA) is a vessel remnant of carotid-vertebrobasilar anastomosis. The aneurysm at the bifurcation of the internal carotid artery (ICA) and PPTA tends to have a broad neck with the branch incorporated into the sac. Because PPTA supplies to the posterior circulation and branches off direct pontine perforators, PPTA preservation should always be considered when treating PPTA aneurysms to avoid ischemic complications.We report a case of the wide-neck ICA-PPTA aneurysm successfully treated with the PulseRider-assisted coil embolization, resulting in complete occlusion with PPTA patency. Relevant anatomy and endovascular strategy of the PPTA aneurysms are discussed.

Pipeline flow diversion with adjunctive coil embolization for internal carotid artery aneurysms following an intradural component: results in 46 consecutive aneurysms from a Japanese single-center experience.

In the treatment of an intracranial aneurysm with the flow diverter, the combined use of coil embolization can help promote subsequent progressive thrombosis within the aneurysm sac and reduce the risk of delayed aneurysm rupture. This study retrospectively reviewed outcomes of patients who had undergone the Pipeline Embolization Device (PED) with adjunctive coil embolization (PED/coil) at a single center to determine its safety and efficiency. Patients with internal carotid artery aneurysms following an intradural component were selected for PED/coil between 2015 and 2020. All patients were premedicated with dual antiplatelet therapy of aspirin plus clopidogrel or prasugrel. A minimal number of PEDs were deployed, with coils inserted using a stent-jail technique, avoiding dense packing. A total of 46 aneurysms (43 patients; median dome size, 11.6 mm; median neck width, 6.3 mm) were treated with PED/coil. The median volume embolization ratio was 14.8%. The degree of angiographic filling at the 6-month and latest angiography showed complete occlusion in 60.5% (26/43) and 70.5% (31/44), respectively. Small (< 10 mm) aneurysms achieved a higher complete occlusion rate in the early period; a lower cumulative incidence of aneurysm occlusion was observed in large and giant (≥ 10 mm) aneurysms (P = .024). The median clinical follow-up was 22 months, and no aneurysm ruptures occurred. Favorable clinical outcomes were achieved, with permanent neurological morbidity of 4.7% and no mortality. PED/coil demonstrated a high angiographic occlusion rate at an early stage. Loosely packed coils are sufficient to obliterate aneurysms effectively.

A Damp-and-Push Technique for the Copolymer (Onyx) Embolization of Dural Arteriovenous Fistula.

BACKGROUND: Copolymer (Onyx) embolization is an effective treatment for dural arteriovenous fistula (dAVF), however, some dAVFs have multiple, high-flow feeding vessels, resulting in insufficient embolization. For the treatment of such patients, we have developed a novel flow-control technique, the 'damp-and-push technique'. The purpose of this study was to evaluate the technical efficiency and safety of this technique. METHODS: Seven patients who had been diagnosed with intracranial dAVF were treated by transarterial Onyx embolization using the damp-and-push technique between 2016 and 2019. This technique was designed to reduce blood flow to the shunt site using a balloon catheter in the major feeding vessel other than the one injected with Onyx, leading to better Onyx penetration and enabling more controlled embolization of complex dAVFs. Retrospectively collected data were reviewed to assess the occlusion rates and clinical outcomes. RESULTS: The dAVF was at a transverse sinus-sigmoid sinus junction in four patients, in the superior sagittal sinus in two, and in the tentorium in one. Five cases were Cognard type Ⅱb and two cases were Cognard type Ⅳ. All the patients were treated by transarterial Onyx injection via the main feeding vessel, combined with flow reduction in the other main feeding vessel using a balloon catheter. Complete occlusion was achieved in six patients and elimination of cerebral venous reflux was achieved in all the patients. There were no immediate or delayed post-interventional complications. CONCLUSIONS: Transarterial Onyx embolization of dAVF using the damp-and-push technique is safe and yields a high complete occlusion rate.

Deep Learning-Derived High-Level Neuroimaging Features Predict Clinical Outcomes for Large Vessel Occlusion.

Background and Purpose- For patients with large vessel occlusion, neuroimaging biomarkers that evaluate the changes in brain tissue are important for determining the indications for mechanical thrombectomy. In this study, we applied deep learning to derive imaging features from pretreatment diffusion-weighted image data and evaluated the ability of these features in predicting clinical outcomes for patients with large vessel occlusion. Methods- This multicenter retrospective study included patients with anterior circulation large vessel occlusion treated with mechanical thrombectomy between 2013 and 2018. We designed a 2-output deep learning model based on convolutional neural networks (the convolutional neural network model). This model employed encoder-decoder architecture for the ischemic lesion segmentation, which automatically extracted high-level feature maps in its middle layers, and used its information to predict the clinical outcome. Its performance was internally validated with 5-fold cross-validation, externally validated, and the results compared with those from the standard neuroimaging biomarkers Alberta Stroke Program Early CT Score and ischemic core volume. The prediction target was a good clinical outcome, defined as a modified Rankin Scale score at 90-day follow-up of 0 to 2. Results- The derivation cohort included 250 patients, and the validation cohort included 74 patients. The convolutional neural network model showed the highest area under the receiver operating characteristic curve: 0.81±0.06 compared with 0.63±0.05 and 0.64±0.05 for the Alberta Stroke Program Early CT Score and ischemic core volume models, respectively. In the external validation, the area under the curve for the convolutional neural network model was significantly superior to those for the other 2 models. Conclusions- Compared with the standard neuroimaging biomarkers, our deep learning model derived a greater amount of prognostic information from pretreatment neuroimaging data. Although a confirmatory prospective evaluation is needed, the high-level imaging features derived by deep learning may offer an effective prognostic imaging biomarker.

Endoscopic management of an intrasellar arachnoid cyst through the tuber cinereum in an adult: a case report.

The transventricular endoscopic approach is an effective less invasive method for the management of symptomatic intrasellar arachnoid cysts in adults. The open area of the brain tissue defect in the infundibular recess caused by the upward compression of the cyst is a common target site for fenestration from the third ventricle. This report highlighted an alternative approach through the tuber cinereum (denoted as "trans-tuberal"), which enabled the treatment of symptomatic cases with a small opening for cyst fenestration in the infundibular recess.

Predicting Clinical Outcomes of Large Vessel Occlusion Before Mechanical Thrombectomy Using Machine Learning.

Background and Purpose- The clinical course of acute ischemic stroke with large vessel occlusion (LVO) is a multifactorial process with various prognostic factors. We aimed to model this process with machine learning and predict the long-term clinical outcome of LVO before endovascular treatment and to compare our method with previously developed pretreatment scoring methods. Methods- The derivation cohort included 387 LVO patients, and the external validation cohort included 115 LVO patients with anterior circulation who were treated with mechanical thrombectomy. The statistical model with logistic regression without regularization and machine learning algorithms, such as regularized logistic regression, linear support vector machine, and random forest, were used to predict good clinical outcome (modified Rankin Scale score of 0-2 at 90 days) with standard and multiple pretreatment clinical variables. Five previously reported pretreatment scoring methods (the Pittsburgh Response to Endovascular Therapy score, the Stroke Prognostication Using Age and National Institutes of Health Stroke Scale index, the Totaled Health Risks in Vascular Events score, the Houston Intra-Arterial Therapy score, and the Houston Intra-Arterial Therapy 2 score) were compared with these models for the area under the receiver operating characteristic curve. Results- The area under the receiver operating characteristic curve of random forest, which was the worst among the machine learning algorithms, was significantly higher than those of the standard statistical model and the best model among the previously reported pretreatment scoring methods in the derivation (the area under the receiver operating characteristic curve were 0.85±0.07 for random forest, 0.78±0.08 for logistic regression without regularization, and 0.77±0.09 for Stroke Prognostication using Age and National Institutes of Health Stroke Scale) and validation cohorts (the area under the receiver operating characteristic curve were 0.87±0.01 for random forest, 0.56±0.07 for logistic regression without regularization, and 0.83±0.00 for Pittsburgh Response to Endovascular Therapy). Conclusions- Machine learning methods with multiple pretreatment clinical variables can predict clinical outcomes of patients with anterior circulation LVO who undergo mechanical thrombectomy more accurately than previously developed pretreatment scoring methods.

[Treatment Strategies for Unruptured Multiple Intracranial Aneurysms].

OBJECTIVE: Unruptured aneurysms are often discovered incidentally on MRI. In some patients, multiple aneurysms cannot be treated with only craniotomy or endovascular surgery. When both craniotomy and endovascular surgery are deemed necessary, craniotomy is generally performed first because of the use of antiplatelet agents involved, followed by endovascular surgery several months later. However, no clear criteria for this treatment policy have been elicited. We investigated therapeutic outcomes in patients with aneurysms treated by craniotomy followed by endovascular surgery at our hospital. PATIENTS AND METHODS: This was a retrospective study including patients undergoing craniotomy clipping of one or more unruptured aneurysms at one site and endovascular surgery for those at a different site, between January 2012 and May 2018 in our hospital. The types of treatment, interval between treatments, complications, and other factors were analyzed. RESULTS: This study included 22 patients who underwent a total of 25 craniotomies and 23 endovascular surgeries. The mean time from final craniotomy to initial endovascular surgery was 118 days. Although treatment-related complications occurred in three patients, they were not associated with the time interval between craniotomy and endovascular surgery or the timing of the start of the antiplatelet therapy. CONCLUSIONS: The treatment was successful and was carried out safely and appropriately by first performing the craniotomy, followed by a set interval of time before starting the antiplatelet therapy, and then performing the endovascular surgery. Further studies analyzing more cases are required to establish the criteria better, such as the appropriate interval time between treatments.

Pipeline embolization device dynamics: prediction of incomplete occlusion by elongation from nominal length.

OBJECTIVE: According to benchtop studies, the oversizing of a Pipeline embolization device (PED) relative to the parent artery leads to a significant increase in porosity and potentially compromises aneurysm occlusion as well as transitional zone (TZ) formation around the neck of aneurysms. However, no clinical assessment has been reported. Here this potential was studied by measuring the dynamic changes of PEDs in the clinical time course. METHODS: The authors retrospectively examined 124 anterior circulation unruptured aneurysms in 114 consecutive patients treated with a PED between July 2015 and December 2020 at their institution. The authors excluded 77 cases of 68 patients with adjunctive coil embolization or multiple stents that could affect the PED dynamics and measurements, and 47 aneurysms in 46 patients were included. Measurements were performed before, immediately after, and 6 months after treatment, and then at intervals of 6 months to 1 year after that for nonocclusion cases. RESULTS: Complete occlusion was achieved in 79.0% and incomplete occlusion in 21.0% at last follow-up. The PED length immediately after deployment was 136% nominal length. A multivariable regression analysis revealed that age (OR 1.11/year; p = 0.02) and PED elongation from nominal length (OR 1.31/mm; p = 0.012) were independently associated with a higher rate of incomplete occlusion at the last follow-up. TZ formation did not affect the occlusion rate. CONCLUSIONS: PED elongation from the nominal length is a new predictor of incomplete aneurysm occlusion. The PED showed vascular remodeling by changing its diameter and length in the clinical course. TZ formation was remodeled and did not affect the occlusion rate.

Intraorbital Dural Arteriovenous Fistula Treated by Transarterial Embolization Using Onyx: A Case Report.

Objective: Intraorbital dural arteriovenous fistula (IO-dAVF) is a rare condition, and treatment options vary from case to case. We report a case of transarterial embolization (TAE) for IO-dAVF. Case Presentation: A 62-year-old male complained of gradually worsening pain, hyperemia, and visual impairment in the right eye. He did not exhibit diplopia or exophthalmos. Cerebral angiography revealed an arteriovenous fistula in the right orbit. The feeding arteries were the ophthalmic artery (OphA) and the artery of the superior orbital fissure (ASOF), with the superior ophthalmic vein (SOV) as the main draining vein. The venous pathway from the SOV was not clearly visible, and considering the risk of blindness with TAE from the OphA, TAE from the ASOF was performed. Onyx 18 was selected as the liquid embolic material and injected through a microcatheter placed in the internal maxillary artery. Occlusion up to the SOV was achieved, and the shunt flow completely disappeared. Normal blood flow in the OphA was maintained, hyperemia improved, and no complications were observed. Conclusion: In cases of IO-dAVF, when transvenous embolization is difficult to perform, TAE using Onyx from the vessel of the external carotid artery system may be preferred over OphA.

Treatment Results of Carotid Artery Stenting with an Open-Cell Stent: Analysis of 734 Consecutive Cases at a Single Center.

OBJECTIVE: In carotid artery stenting (CAS) for internal carotid artery stenosis, the stent is often selected according to the plaque properties and arterial tortuosity. In our institute, an open-cell stent is used as the first-line stent regardless of the characteristics of the lesion. This study was performed to examine the outcome of CAS with an open-cell stent as the real-world results. METHODS: In total, 811 CAS procedures using open-cell stents were performed for internal carotid artery stenosis from April 2002 to December 2019. Of these patients, we excluded those with hyperacute conditions for which CAS was performed within 3 days of onset, those in whom acute mechanical thrombectomy was performed simultaneously with CAS, and those with stenosis due to arterial dissection. Thus, 734 patients were retrospectively analyzed. Perioperative and long-term outcomes and risk factors for perioperative infarction were investigated. RESULTS: The periprocedural stroke rate and mortality rate were 3.7% (27/734) and 0.4% (3/734), respectively. Low-echoic plaque was a significant risk factor for periprocedural stroke in both univariate (P < 0.03) and multivariate (odds ratio, 2.69; 95% confidence interval, 1.14-6.66; P = 0.02) analyses. Cerebral infarction and high grade restenosis were observed in 15 (2.0%) and 17 (2.3%) patients during a median 50-month follow-up. CONCLUSIONS: CAS with open-cell stents showed good results in terms of both the postoperative stroke incidence and long-term severe restenosis rate. However, low-echoic plaque was a risk factor for perioperative stroke incidence, which should be considered when deciding on the indication for CAS with an open-cell stent.

Novel use of a closed-tip stent retriever to prevent distal embolism in the posterior circulation: illustrative case.

BACKGROUND: In mechanical thrombectomy for tandem occlusions in vertebrobasilar stroke, distal emboli from the vertebral artery lesion should be prevented. However, no suitable embolic protection devices are currently available in the posterior circulation. Here, the authors describe the case of a vertebral artery lesion effectively treated with a closed-tip stent retriever as an embolic protection device in the posterior circulation. OBSERVATIONS: A 65-year-old male underwent mechanical thrombectomy for basilar artery occlusion, with tandem occlusion of the proximal vertebral artery. After basilar artery recanalization via the nonoccluded vertebral artery, a subsequent mechanical thrombectomy was performed for the occluded proximal vertebral artery. To prevent distal embolization of the basilar artery, an EmboTrap III stent retriever was deployed as an embolic protection device within the basilar artery to successfully capture the thrombus. LESSONS: A stent retriever with a closed-tip structure can effectively capture thrombi, making it a suitable distal embolic protection device in the posterior circulation.

Clinical evaluation of mechanical thrombectomy for patients with posterior circulation occlusion: A retrospective study.

OBJECTIVE: Although consensus has been reached regarding the use of mechanical thrombectomy for acute large anterior circulation occlusion, its effectiveness in patients with posterior circulation occlusion remains unclear. This study aimed to establish the determining factors for good clinical outcomes of mechanical thrombectomy for posterior circulation occlusion. METHODS: We extracted cases of acute large vessel occlusion (LVO) in the posterior circulation from a database comprising 536 patients who underwent mechanical thrombectomy at our hospital between April 2015 and March 2021. RESULTS: Fifty-two patients who underwent mechanical thrombectomy for LVO in the posterior circulation were identified. Five patients with simultaneous occlusion of the anterior and posterior circulation were excluded; finally, 47 patients were included in this study. The median patient age was 78 years, and 36% of the patients were women. The median National Institutes of Health Stroke Scale (NIHSS) score on admission was 31, the median posterior circulation-Alberta Stroke Program Early Computed Tomography Score (pc-ASPECTS) was 8, and the median Basilar Artery on Computed Tomography Angiography (BATMAN) score was 6. The rate of good recanalization (Thrombolysis in Cerebral Infarction scale grades 2b and 3) was 96%, and a good prognosis (modified Rankin Scale score of 0-2 at 90 days) was achieved in 19 patients (40%). The median pc-ASPECTS was significantly higher in the good prognosis group than in the poor prognosis group (10 vs. 7; p = 0.007). The median NIHSS score at presentation was significantly lower in the good prognosis group than in the poor prognosis group (17 vs. 34; p = 0.02). The median BATMAN score was significantly higher in the good prognosis group than in the poor prognosis group (8 vs. 3.5; p = 0.0002). Multivariate analysis showed that an NIHSS score ≦ 20 at presentation was the only independent factor for good prognoses. CONCLUSION: The prognosis of mechanical thrombectomy for posterior circulation LVO was better in patients with lower NIHSS scores at presentation.

Bacterial Meningitis Following Aneurysmal Subarachnoid Hemorrhage and Its Association with Cerebral Vasospasm.

Aneurysmal subarachnoid hemorrhage (aSAH) is a critical condition with high in-hospital mortality rates. Delayed cerebral ischemia (DCI), a secondary complication associated with aSAH, can also contribute to morbidity and mortality. Although draining the hematoma from the subarachnoid space has been considered effective in preventing DCI, the placement of a drainage system could increase the risk of bacterial meningitis and ventriculitis. This study aimed to examine the association between meningitis following aSAH and the occurrence of DCI, focusing on the role of cerebral vasospasm. Patients who underwent endovascular coiling or surgical clipping for aSAH from April 2001 to March 2022 were included in this study, while those who did not undergo postoperative drainage were excluded. The patient's clinical characteristics, treatment modalities, and outcomes were then analyzed, after which logistic regression was used to assess the odds ratios (OR) for DCI. A total of 810 patients with aSAH were included in this study. Meningitis following aSAH was identified as an independent factor associated with DCI (odds ratio 5.0 [95% confidence intervals (CI) 2.3-11]). Other significant factors were female sex (odds ratio 1.5 [95% CI 0.89-2.5]) and surgical clipping (odds ratio 2.1 [95% CI 1.3-3.4]). This study demonstrated a significant association between meningitis following aSAH and the development of DCI, suggesting that the inflammatory environment associated with meningitis may contribute to cerebral vasospasm. Early recognition and treatment of meningitis in patients with aSAH could reduce the risk of DCI and improve patient outcomes.

Multidisciplinary Approach for the Management of a Case With Craniofacial Penetrating Injury Compressing the Internal Carotid Artery.

A craniofacial penetrating injury can be severe when a foreign object reaches the skull base, causing an intracranial hemorrhage or a pseudoaneurysm. We report a case of sharp craniofacial injury in which a thin wooden rod moved from the orbit to the internal carotid artery. With a multidisciplinary team consisting of neurosurgeons, plastic surgeons, and otolaryngologists, the foreign body was safely removed, and the patient healed without complications or sequelae. Careful risk management is necessary when treating a case of craniofacial penetrating injury because the depth of the foreign body cannot be determined from the external appearance, making it challenging to decide on the severity of the damage from the injury.

Incidence and Outcomes of Aneurysmal Subarachnoid Hemorrhage: A Multicenter Retrospective Registry-based Descriptive Trial in Kobe City.

The current study aims to evaluate the incidence and results of aneurysmal subarachnoid hemorrhage (aSAH) throughout Kobe City. Based on a multicenter retrospective registry-based descriptive trial involving all 13 primary stroke centers in Kobe City, patients with aSAH treated between October 2017 and September 2019 were studied. A total of 334 patients were included, with an estimated age-adjusted incidence of 11.12 per 100,000 person-years. Curative treatment was given to 94% of patients, with endovascular treatment (51%) preferred over surgical treatment (43%). Of the patients, 12% were treated by shunt surgery for sequential hydrocephalus with a worse outcome at 30 days or discharge (14% vs. 46%, odds ratio (OR): 0.19, 95% confidence interval (CI): 0.088-0.39, p-value <0.001). As for vasospasm and delayed cerebral ischemia, most patients were given intravenous fasudil infusion (73%), with endovascular treatment for vasospasm in 24 cases (7.2%). The fasudil group had more good outcomes (42% vs. 30%, OR: 1.64, 95% CI: 0.95-2.87, p-value = 0.075) and significantly less death (3.3% vs. 35%, OR: 0.064, 95% CI: 0.024-0.15, p-value <0.001) at 30 days or discharge. Mortality rose from 12% at 30 days or discharge to 17% at 1 year, but neurological function distribution improved over time (modified Rankin Scale 0-2 was 39% at 30 days or discharge, 53% at 60 days, and 63% at 1 year). Our retrospective registered trial presented various statistics on aSAH, summarizing the current treatment status and prognosis.

First-in-human trial of a self-expandable, temporary dilation system for intracranial atherosclerotic disease in patients presenting with acute ischemic stroke.

BACKGROUND: Intracranial atherosclerotic disease (ICAD) significantly contributes to ischemic stroke, especially among Asian populations. Large vessel occlusion (LVO) due to underlying ICAD accounts for 15-35% of acute ischemic stroke cases requiring endovascular therapy. However, the successful recanalization rate of ICAD-related LVO remains lower. The TG dilator is a self-expandable device, temporarily dilating ICAD-related blocked blood vessels. OBJECTIVE: To demonstrate TG dilator safety and efficacy for ICAD-related acute ischemic stroke. METHODS: This was a single-arm, open-label, non-randomized, prospective, multicenter, and investigator-initiated trial that involved patients undergoing TG dilator application for acute ischemic stroke caused by ICAD-related LVO or severe stenosis. RESULTS: We enrolled 10 patients in this trial between November 2022 and April 2023. The median (IQR) age was 68 (59.3-75.3) years. Before using the dilator, seven patients received stent retriever treatment. All 10 patients were prescribed a loading dose of aspirin with prasugrel. The median application time was 10 (10-12) min. At the end of the procedure, we achieved significant recanalization immediately in all patients. The stenosis/occlusion decreased from 100% (100-100) to 68% (56.3-75.3). No patient experienced recurrent ischemic stroke or reocclusion within 90 days. We achieved a modified Rankin scale score of 0-2 in 8 patients by day 90. We detected no cases of intracranial hemorrhage, equipment failure, distal embolism, vasospasm, dissection, or perforation requiring intervention. CONCLUSIONS: Acute revascularization using the TG dilator on patients with ICAD-related LVO or severe stenosis did not cause any significant adverse event, and consistently improved blood flow at 90 days.

First-in-human trial of Center Wire for neuroendovascular therapy to avoid guidewire-related complications.

BACKGROUND: An exchange maneuver is useful for the delivery of devices to target vessels. However, hemorrhagic complications can occur due to vessel perforation during an exchange maneuver. In addition, the exchange is often challenging due to unfavorable anatomy. Center Wire is an exchange-length wire with a nondetachable stent that was developed to improve navigation and stability during exchange maneuvers. The aim of this study is to investigate the safety and efficacy of Center Wire of the anchor wire technique during neuroendovascular treatment. METHODS: Ten patients with intracranial aneurysms were treated after signing a Certified Review Board-approved consent. Anchor wire technique was used in all patients to navigate catheters to the target vessel for aneurysm treatment. RESULTS: Anchor wire technique was successfully applied in all 10 cases using Center Wire. One device-related incident of vasospasm occurred which was asymptomatic. No device-related dissection, perforation, or thromboembolic events occurred. One patient had intraoperative aneurysm rupture during coil placement which was treated immediately without clinical consequences. Two patients had postoperative ischemic strokes due to thrombotic occlusion of branches originating from the aneurysm which were unrelated to the device. CONCLUSIONS: This first-in-human trial of Center Wire demonstrated the safety and efficacy of the anchor wire technique for neuroendovascular treatment in a strictly regulated prospective registry trial.

First-in-human trial of Stabilizer device in neuroendovascular therapy.

Objectives: Flow diverter or stent implantation to intracranial target lesion requires large inner diameter microcatheter navigation. The exchange method using stiff long wire is often necessary if it is difficult to navigate over the regular guidewire. However, this method has an intrinsic risk of vessel damage and may cause severe complications. We investigated the safety and efficacy of a new device, the Stabilizer device for navigation in a first-in-human clinical trial under the Certified Review Board agreement. Materials and methods: The Stabilizer is a 320 cm length exchange wire with a stent for anchoring and is compatible with a 0.0165" microcatheter. The trial design is a prospective single-arm open-label registry. Inclusion criteria are elective flow diverter treatment or stent-assisted coiling, expected to be difficult to navigate a microcatheter with a regular micro guidewire, and obtained documented consent. The primary endpoint of the study was a hemorrhagic complication. Results: Five patients were enrolled in this trial. The median age is 52 years, ranges from 41 to 70, and all patients were female. Three aneurysms were located on the internal carotid artery, one on the vertebral artery, and one on the basilar artery. Basilar artery aneurysm was treated by stent-assisted coiling and others were treated by flow diverter deployment. All cases successfully navigate microcatheter for the treatment by the trial method using Stabilizer device without any adverse event. Conclusions: The results from this first-in-human consecutive five cases show the safety of the Stabilizer device in neuro-endovascular therapy for navigation of devices to the intracranial target lesion.