scholarly journals Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial

2021 ◽  
pp. neurintsurg-2021-017469
Author(s):  
Cameron G McDougall ◽  
Orlando Diaz ◽  
Alan Boulos ◽  
Adnan H Siddiqui ◽  
Justin Caplan ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Multicenter Trial ◽  
Parent Artery ◽  
Stent System ◽  
Safety Endpoint ◽  
Performance Benchmarks ◽  
Registration Number ◽  
The Usa ◽  
Effectiveness Endpoint

ObjectiveTo evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA.Methods145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed.Results145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%)ConclusionAs compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms.Clinical registration numberNCT01801007

scholarly journals The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study

2018 ◽  
Vol 10 (10) ◽  
pp. 969-974 ◽  
Author(s):  
Benjamin Gory ◽  
Raphaël Blanc ◽  
Francis Turjman ◽  
Jérôme Berge ◽  
Michel Piotin
Keyword(s):  
Intracranial Aneurysms ◽  
Vascular Reconstruction ◽  
Dome Height ◽  
Endovascular Coiling ◽  
Anterior Communicating Artery ◽  
Parent Artery ◽  
Safety Endpoint ◽  
Post Marketing ◽  
Effectiveness Endpoint ◽  
Primary Safety Endpoint

Background and purposeThe Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up.Materials and methodsThe Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond–Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months.ResultsTwenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19).ConclusionsThis prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms.Registered clinical trialNCT02125097;Results.

scholarly journals Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device

2015 ◽  
Vol 8 (9) ◽  
pp. 894-897 ◽  
Author(s):  
David Fiorella ◽  
Adam Arthur ◽  
Alan Boulos ◽  
Orlando Diaz ◽  
Pascal Jabbour ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Multicenter Trial ◽  
Clinical Endpoints ◽  
Clinical Events ◽  
Low Profile ◽  
The Us ◽  
Safety Endpoint ◽  
Registration Number ◽  
Bare Platinum Coils

IntroductionThe low-profile visualized intraluminal support (LVIS) device is a new, braided, intracranial microstent designed for stent-assisted coiling.ObjectiveTo present the results of a single-arm, prospective, multicenter trial of the LVIS for treatment of wide-necked intracranial aneurysms.Methods31 patients with unruptured, wide-necked (neck ≥4 mm or dome:neck ratio ≤2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at six US centers (investigational device exemption G110014). Clinical follow-up was conducted at 30 days and 6 months. Angiographic follow-up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. ‘Probable benefit’ was defined as ≥90% angiographic occlusion at 6 months. An independent core laboratory adjudicated the angiographic results. An independent clinical events committee adjudicated the clinical endpoints.ResultsAverage aneurysm size was 7.2 mm (SD 3.8) and average neck width was 4.6 mm (SD 1.8). 68% of patients had a dome:neck ratio ≤2. LVIS placement was technically successful in 29/31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months than at baseline. 26/28 (92.9%) treated aneurysms with 6-month angiographic follow-up demonstrated ≥90% angiographic occlusion. 21/28 (75%) were completely occluded at follow-up.ConclusionsThe LVIS device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up.Trial registration numberNCT01541254.

Abstract 120: Surpass Flow Diverter for Endovascular Treatment of Intracranial Aneurysms - A Multicenter Preliminary Clinical and Angiographic Experience in 161 Patients with 186 Aneurysms

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Ajay K Wakhloo ◽  
Pedro Lylyk ◽  
Joost de Vries ◽  
Matthew J Gounis ◽  
Alexandra Biondi ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Experimental Studies ◽  
Flow Diverter ◽  
Posterior Circulation ◽  
Parent Artery ◽  
Anterior Circulation ◽  
Neck Size ◽  
Wide Range ◽  
New Generation

Objective: Validated through experimental studies a new generation of flow diverters (Surpass™ FD) was evaluated for treatment of intracranial aneurysms (IA). We present our multicenter preliminary clinical and angiographic experience. METHODS: To achieve the calculated flow disruption between the parent artery and aneurysm for thrombosis, single FDs were placed endovascularly in parent arteries. Implants measured 2.5-5.3mm in diameter with a length of 10-80mm. Patients were enrolled harboring a wide range large and giant wide-neck, fusiform and multiple small and blister-type aneurysm. Clinical and angiographic follow-up were performed at 1-3, 6, and 12 months. RESULTS: A total of 186 consecutive IA in 161 patients (mean age 57.1 years) were treated at 33 centers. Fifty-three aneurysms were smaller than 5 mm, 64 were 5-9.9mm in diameter, 47 were 10-20mm in diameter, and 22 were larger than 20mm (10.4±0.7mm, neck size 6.0±0.5mm [mean±SEM]) . The aneurysms originated in 63.4% from the internal carotid artery; 22% and 14.5% of the lesions were located in the anterior circulation distal to Circle of Willis and posterior circulation respectively. Technical success was achieved in 182 aneurysms (98%); average number of devices used per aneurysm was 1.05. Permanent morbidity and mortality during the follow-up period of mean 8.4months (range 1-24 months) including periprocedural complications for patients with aneurysms of the anterior circulation were encountered in 5 (3.7%) and 2 (1.5 %) patients respectively and 1 (3.7%) and 4 (14.8%) respectively for patients with aneurysms of the posterior circulation location. One-hundred-ten patients (70.5%) harboring 127 (70.2%) were available for clinical and angiographic follow-up and showed a complete or near complete aneurysm occlusion in 63 (81.8%) of the ICA. Aneurysms of the ICA≥10mm that were completely covered by FD and not previously stent-treated with a minimum of 6 months follow-up available in 16 patients showed a complete obliteration in 81.3% (n=13) and >90% occlusion in remaining 3 patients. CONCLUSION: Preliminary data demonstrate high safety and efficacy of a new generation of FD for a wide range of IA of the anterior and posterior circulation with a single implant.

scholarly journals Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

2020 ◽  
Vol 12 (11) ◽  
pp. 1107-1112 ◽  
Author(s):  
Hal Rice ◽  
Mario Martínez Galdámez ◽  
Markus Holtmannspötter ◽  
Laurent Spelle ◽  
Konstantinos Lagios ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Neurological Complications ◽  
Parent Artery ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Pipeline Embolization Device ◽  
Link Type ◽  
Post Market ◽  
Safety Endpoint ◽  
Primary Safety Endpoint

BackgroundThe first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.MethodsThe SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.ResultsOf 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.ConclusionsThe findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population.Clinical trial registration-URLhttp://www.clinicaltrials.gov. Unique identifier: NCT02719522.

Introduction: History and Development of Flow Diverter Technology and Evolution

Neurosurgery ◽  
2019 ◽  
Vol 86 (Supplement_1) ◽  
pp. S3-S10 ◽  
Author(s):  
Anna Luisa Kühn ◽  
Matthew J Gounis ◽  
Ajit S Puri
Keyword(s):  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Parent Artery ◽  
Introduction History ◽  
United States Food ◽  
Diseased Vessel ◽  
States Food ◽  
Device Deployment ◽  
Bench Testing ◽  
Flow Diverters

Abstract The introduction of flow diverter technology to the field of neurointervention has revolutionized the treatment of intracranial aneurysms. The therapy approach has shifted from intrasaccular aneurysm treatment to exclusion of the aneurysm from the blood circulation with remodeling of the parent artery. Previously, “difficult”-to-treat aneurysms including fusiform and blister aneurysms, but also aneurysms arising from a diseased vessel segment, can now be safely and permanently treated with flow diverters.  A little over a decade ago, after extensive bench testing and refinement of the flow diverter concept, the device was eventually available for clinical use and today it has become a standard treatment for intracranial aneurysms. Currently, United States Food and Drug Administration (FDA)-approved flow diverters are the Pipeline Embolization Device (Medtronic) and the Surpass Streamline Flow Diverter (Stryker).  The devices can either be delivered or deployed via a standard femoral artery approach or a radial artery approach. Other considerations for catheter setup and device deployment strategies depending on aneurysm location or vessel anatomy are described.

Abstract 1122‐000071: Large and Giant Intracranial Aneurysms, Clinico‐Radiological Outcome and Predictors with Flow Diverter Stent

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Islam El Malky ◽  
Ayman Zakaria ◽  
Essam Abdelhameed ◽  
Hazem Abdelkhalek
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Artery Occlusion ◽  
Parent Artery ◽  
Giant Aneurysms ◽  
Complex Aneurysms ◽  
Parent Artery Occlusion ◽  
Large And Giant Aneurysms ◽  
Flow Diverters

Introduction : Endovascular treatment for large and giant aneurysms has included either a reconstructive approach or a deconstructive approach by parent artery occlusion. 1,2 Stent‐assisted coiling and balloon‐assisted coiling were alternative techniques developed to deal with such complex aneurysms, but studies have shown less expected efficacy. This study aims to assess the safety and efficacy of the flow diverter stents for treating large and giant intracranial aneurysms and to examine possible predictors for radiological and clinical outcomes such as location and presence of branching artery, bifurcation, and adjuvant coiling. Methods : This study had been conducted on 65 consecutive patients with 65 large and giant aneurysms (size ≥ 10 mm) treated with flow diverters; Periprocedural complications were reported in all patients and clinical outcomes. Follow‐up angiography was done for 60 patients (92.3%) at 12 months. Results : The study included 65 patients who harbored 65 aneurysms. The median age was 55.5 years (IQR: 44.25 ‐ 62.75 years), the female represented 70.8 % of all patients. The clinical presentation had been reported (Headache, cranial nerve palsy, motor deficit, seizures, and visual field defect in 40 patients (61.5%), nine patients (13.8%), seven patients (10.8%), five patients (7.7%), and four patients (6.2%) respectively. The vascular risk factors had been reviewed (HTN, DM, smoking, and Hyperlipidemia in 25 patients (9.2%), Six patients (9.2%), sixteen (24.6%), and 10 patients (15.4%) respectively). The median size of aneurysms was 16.4 mm (IQR: 12.50 ‐ 23.85 mm) and the median neck width was 7.15 mm (IQR: 5.85‐10.24 mm). Fourteen aneurysms (21.4 %) had previous treatment, eleven aneurysms (16.9%) were treated by coils only, one case (1.5%) by assisted procedure, one case (1.5%) by previous FDS, and parent artery occlusion in one case (1.5%). Complete occlusion in 50 from 60 aneurysms (83.4%), neck remnant in 8 aneurysms (13.3%), and sac remnant in two aneurysms (3.3%). Periprocedural problems were encountered in 14 patients (21.5%) with morbidity in six patients (9.2%) and mortality in one patient (1.5%). Univariate and multivariate logistic regression analysis was used to discover possible predictors of combined mortality and morbidity and occlusion in Table (1). Conclusions : From this study, it could be concluded that Endovascular treatment of the large and giant aneurysms with flow diverters represents a safe method for treating this kind of complex intracranial aneurysms. Complex aneurysms with branching artery and bifurcation were associated with aneurysm persistence and complications respectively while the location of the aneurysm was the only predictor for clinical outcome.

WingSpan Stent System in the endovascular treatment of intracranial aneurysms: clinical experience with midterm follow-up results

2008 ◽  
Vol 109 (3) ◽  
pp. 445-453 ◽  
Author(s):  
Kivilcim Yavuz ◽  
Serdar Geyik ◽  
Isil Saatci ◽  
H. Saruhan Cekirge
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Treatment Strategies ◽  
Radial Force ◽  
Parent Artery ◽  
Aneurysm Neck ◽  
Stent System ◽  
Thrombosis Rate ◽  
Dissecting Aneurysms

Object The WingSpan stent is a new self-expandable neurovascular stent designed for endovascular treatment of intracranial atheromatous lesions. The authors report their experience with the use of this stent for the endovascular treatment of intracranial aneurysms. Methods Thirty-seven patients with 40 wide-necked intracranial aneurysms were treated using the WingSpan stent. Twenty-two aneurysms (55%) were small and 18 (45%) were large or giant. In all but 4 aneurysms, embolization was completed by packing the aneurysm sac with platinum coils. In 4 dissecting aneurysms that were fusiform or too small and wide necked to be catheterized, the stent was used alone. In these cases, the stent bridged the aneurysm neck to allow for flow redirection and the potential stent-induced endothelization effect. Results Follow-up angiograms obtained in 3 of 4 aneurysms, treated with only stent placement, demonstrated aneurysmal thrombosis and parent artery remodeling in 2 patients and moderate decrease in size in 1. Follow-up angiography obtained at 6 months to 1 year in 31 aneurysms after stent-supported coil embolization demonstrated complete occlusion in 23 aneurysms (74.2%) with a progressive thrombosis rate of 66.7% (10 of 15 aneurysms), and a recanalization rate of 16.1%. Conclusions In treating wide-necked intracranial aneurysms, the WingSpan Stent System is very flexible, secure, and effective. Its delivery system is very easy and exact in that it exerts higher outward radial force, thus providing an excellent conformability and a strong scaffold to hold the coils in place. It may offer an effective treatment when used alone in some fusiform or very wide-necked, small dissecting aneurysms in which other surgical or endovascular treatment strategies are not deemed feasible.

scholarly journals Flow Diverters for Intracranial Aneurysms

2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Yazan J. Alderazi ◽  
Darshan Shastri ◽  
Tareq Kass-Hout ◽  
Charles J. Prestigiacomo ◽  
Chirag D. Gandhi
Keyword(s):  
Antiplatelet Therapy ◽  
Intracranial Aneurysms ◽  
Evidence Base ◽  
Flow Diverter ◽  
Parent Artery ◽  
Comparative Efficacy ◽  
Parent Vessel ◽  
Wide Neck ◽  
Endovascular Devices ◽  
Flow Diverters

Flow diverters (pipeline embolization device, Silk flow diverter, and Surpass flow diverter) have been developed to treat intracranial aneurysms. These endovascular devices are placed within the parent artery rather than the aneurysm sac. They take advantage of altering hemodynamics at the aneurysm/parent vessel interface, resulting in gradual thrombosis of the aneurysm occurring over time. Subsequent inflammatory response, healing, and endothelial growth shrink the aneurysm and reconstruct the parent artery lumen while preserving perforators and side branches in most cases. Flow diverters have already allowed treatment of previously untreatable wide neck and giant aneurysms. There are risks with flow diverters including in-stent thrombosis, perianeurysmal edema, distant and delayed hemorrhages, and perforator occlusions. Comparative efficacy and safety against other therapies are being studied in ongoing trials. Antiplatelet therapy is mandatory with flow diverters, which has highlighted the need for better evidence for monitoring and tailoring antiplatelet therapy. In this paper we review the devices, their uses, associated complications, evidence base, and ongoing studies.

Republished: The first North American use of the Pipeline Flex flow diverter

2015 ◽  
Vol 8 (2) ◽  
pp. e8-e8 ◽  
Author(s):  
Edward AM Duckworth ◽  
Christopher Nickele ◽  
Daniel Hoit ◽  
Andrey Belayev ◽  
Christopher J Moran ◽  
...  
Keyword(s):  
Paradigm Shift ◽  
Intracranial Aneurysms ◽  
Second Generation ◽  
Relevant Literature ◽  
Treatment Strategies ◽  
Flow Diverter ◽  
Flow Diversion ◽  
Current State ◽  
The Usa ◽  
New Treatment

Flow diversion for the management of intracranial aneurysms represents a paradigm shift in how aneurysms are managed. The Pipeline embolization device (PED) is, to date, the only flow diverter approved for use in the USA by the Food and Drug Administration. Limitations and complications with new treatment strategies are inevitable, and with the PED there have been reports of complications, most commonly with challenging deployments. Once deployment has been initiated, the device is ‘one-way’; it can only be deployed further or removed. Yet, situations arise in which the ability to recapture or reposition the device would be advantageous. A second-generation Pipeline has been developed that addresses these concerns. We report the first use in North America of this second-generation Pipeline device: the Pipeline Flex. We discuss our rationale for using the device, our impressions of its operation, and the relevant literature concerning the current state of flow diversion.

scholarly journals Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes

2021 ◽  
pp. neurintsurg-2020-017115
Author(s):  
Brian T Jankowitz ◽  
Ashutosh P Jadhav ◽  
Bradley Gross ◽  
Tudor G Jovin ◽  
Abdulnasser A Alhajeri ◽  
...  
Keyword(s):  
Posterior Circulation ◽  
Class I ◽  
Parent Artery ◽  
Primary Efficacy ◽  
Open Label ◽  
Technical Success Rate ◽  
Stent System ◽  
Registration Number ◽  
Aneurysm Occlusion ◽  
One Year

BackgroundStent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results.ObjectiveTo present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs.MethodsThe ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee.ResultsThe ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively.ConclusionsIn the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance.Trial registration numberhttps://clinicaltrials.gov/ct2/show/NCT02340585.

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