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.

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 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 Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion

2020 ◽  
Vol 13 ◽  
pp. 175628642096782
Author(s):  
Bin Luo ◽  
Huibin Kang ◽  
Hongqi Zhang ◽  
Tianxiao Li ◽  
Jianmin Liu ◽  
...  
Keyword(s):  
Blood Flow ◽  
Intracranial Aneurysms ◽  
Registry Study ◽  
Vessel Occlusion ◽  
Clinical Trial Registration ◽  
Pipeline Embolization Device ◽  
Venous Phase ◽  
Aneurysm Occlusion ◽  
Occlusion Rate ◽  
Stent Stenosis

Background and Purpose: The Pipeline Embolization Device (PED, Covidien/Medtronic) is widely used to treat intracranial aneurysms. This PED in China post-market multi-center registry study (PLUS) investigated safety and effectiveness of the PED for intracranial aneurysms in the Chinese population. Methods: This was a panoramic, consecutive, real-world cohort registry study. Patients treated with PED with or without coils between November 2014 and October 2019 at 14 centers in China were included, and those treated by parent vessel occlusion or other stents were excluded. Study outcomes included angiographic evaluation of aneurysm occlusion, complications, in-stent stenosis, and predictors of aneurysm occlusion. A central committee reviewed all imaging and endpoint events. Results: In total, 1171 patients with 1322 intracranial aneurysms were included. The total occlusion rate was 81.4% (787/967) at mean follow-up of 8.96 ± 7.50 months, with 77.1% (380/493) occlusion in the PED alone and 85.9% (407/474) in the PED plus coiling group. On multi-variate analysis, female sex, hyperlipidemia, vertebral aneurysms, PED plus coiling, and blood flow detained to venous phase were significant predictors of aneurysm occlusion. In posterior circulation cohort, there was no variable associated with aneurysm occlusion. In-stent stenosis predictors included current smoking and cerebral sclerosis/stenosis. Conclusion: In the largest series on PED of multi-center date of China, data suggest that treatment with the flow-diverting PED in intracranial aneurysms was efficacious. The treatment of PED combined coiling and blood flow detained to venous phase after PED implant were associated with aneurysmal occlusion. The occlusion rate of vertebral aneurysms was higher than other location aneurysms. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03831672.

Intracranial aneurysms managed by parent artery reconstruction using Tubridge: Study protocol for a prospective, multicenter, post-market clinical trial

2020 ◽  
pp. 159101992097623
Author(s):  
Qiaowei Wu ◽  
Li Li ◽  
Qiuji Shao ◽  
Tianming Xu ◽  
Kaitao Chang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intracranial Aneurysms ◽  
Parent Artery ◽  
Reconstruction Technique ◽  
Long Term Outcomes ◽  
Complete Occlusion ◽  
Post Market ◽  
Occlusion Rate

Background As a new endovascular reconstruction technique, flow diverter (FD) shows excellent efficacy and safety for treatment of intracranial aneurysms. In a previous multicenter, randomized, controlled, pre-market study, Tubridge FD showed remarkably higher complete occlusion rate compared with traditional stent-assisted coiling. However, a nonsignificant higher complication rate in the Tubridge group was noted. Considering the learning curve, the safety, and long-term outcomes of Tubridge FD should be verified in new prospective, real world, multicenter, post-market trials. Methods This study is a prospective, multicenter, single-arm, post-market clinical trial that evaluates the safety and efficacy of Tubridge in the treatment of patients with intracranial aneurysms by reconstructing parent artery. We expect 200 participants who meet the inclusion and exclusion criteria to be included. Clinical information and angiographic results (Raymond–Roy grading scale, RRGS) will be recorded objectively. The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up. Secondary endpoints will include the adequate occlusion rate (RRGS 1 & 2) and the rate of major in-stent stenosis (>50%) at 12-month follow-up, technique success rate, changes of modified Rankin Scale before and after the procedure, the rate of aneurysm related disability, neurological mortality, and all-cause mortality within follow-up period. Discussion This post-market, prospective trial may offer more information on the safety and long-term outcomes of Tubridge FD. When the study is complete, the results may provide us a new strategy for the treatment of intracranial aneurysms. Trial registration: WHO-Chinese Clinical Trial Registry: ChiCTR2000032282.

scholarly journals Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results

2021 ◽  
pp. neurintsurg-2021-017849
Author(s):  
Pierre-Henri Lefevre ◽  
Peter Schramm ◽  
André Kemmling ◽  
Xavier Barreau ◽  
Gaultier Marnat ◽  
...  
Keyword(s):  
Medium Size ◽  
Mri Imaging ◽  
Clinical Trial Registration ◽  
Multicentric Study ◽  
Aneurysm Neck ◽  
Stent System ◽  
Safety Endpoint ◽  
Primary Safety Endpoint ◽  
Major Stroke

BackgroundFew prospective series have described the safety and effectiveness of the Neuroform Atlas Stent System. We aimed to investigate the efficacy and safety of the device in patients treated for unruptured aneurysm.MethodsATLAS EU PMCF is a consecutive, prospective, multicentric study that included patients with unruptured saccular aneurysm of all sizes. Follow-up visits were scheduled at 3–6 months and 12–16 months with digital subtraction angiography (DSA) or MRI imaging follow-up as per the site standard of care. The primary efficacy endpoint was adequate aneurysm occlusion (Raymond Roy occlusion grade I and II) on 12 month angiography. The primary safety endpoint was any major stroke or ipsilateral stroke or neurological death within 12 months.ResultsOf the 106 patients consented, 105 were treated with at least one Neuroform Atlas stent. There was a failed implantation attempt in 1 patient, 85 patients received lateral stenting, and 19 patients received Y-stenting. Mean aneurysm neck size was 4.2 mm (range 1.9–33 mm). Adequate occlusion was observed in 95.1% immediately after the procedure and in 98.9% of cases at 1 year DSA follow-up. Overall, 1.0% (1/102; 95% CI 0.0% to 5.3%) of patients experienced a primary safety endpoint of major stroke. Three minor strokes resulted in a modified Rankin Scale score of 2.ConclusionsIn this multicentric, prospective study, stent-assisted coiling of medium size unruptured aneurysms with the Neuroform Atlas stent resulted in a favorable rate of satisfactory occlusion. In our findings, the use of the Y-stenting technique was associated with increased rates of procedural complications.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02783339.

Embolus Retriever with Interlinked Cages (ERIC) versus conventional stent retrievers for thrombectomy: a propensity score-based analysis

2020 ◽  
pp. neurintsurg-2020-016289
Author(s):  
Célina Ducroux ◽  
Nicolas Renaud ◽  
Romain Bourcier ◽  
Gaultier Marnat ◽  
Igor Sibon ◽  
...  
Keyword(s):  
Propensity Score ◽  
Rescue Therapy ◽  
Clinical Results ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Link Type ◽  
Radiological Data ◽  
Stent Retrievers ◽  
Procedural Outcomes ◽  
Multicenter Registry

BackgroundThe Embolus Retriever with Interlinked Cages (ERIC) is one of the latest devices for thrombectomies. It has several architectural features that are supposed to enhance its ability to remove clots and prevent distal emboli. We aimed to compare ERIC with standard stent retrievers (SRs) using propensity score (PS) matching.MethodsThe clinical and radiological data of all consecutive patients treated with ERIC or standard FDA-approved stent retrievers were collected from a prospective multicenter registry. We compared procedural outcomes (recanalization rates according to the modified Thrombolysis In Cerebral Infarction (mTICI) score and procedural complications) and clinical outcomes (modified Rankin Scale (mRS) and mortality at 3 months). Matching of the populations with PS was performed to account for differences in baseline characteristics.ResultsA total of 1230 patients were included. In both the PS-matched cohort (195 ERIC patients, 630 SR patients) and the inverse probability of treatment weighting PS-adjusted cohort (206 ERIC patients, 1024 SR patients) there was no difference in terms of successful recanalization (modified TICI score ≥2b), good clinical outcome (mRS=0–2 or equal to pre-stroke mRS), or mortality at 3 months. Patients treated with first-line ERIC had a higher rate of complete recanalization (mTICI 3); however, they also required more passes and more frequent rescue therapy than the SR patient group.ConclusionIn a large multicenter registry with PS matching, the ERIC device provided equivalent angiographic and clinical results to conventional SRs.Clinical trial registrationURL: http://www.clinicaltrials.gov Unique identifier: NCT03776877.

scholarly journals Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series

2017 ◽  
Vol 10 (6) ◽  
pp. 553-559 ◽  
Author(s):  
Laurent Pierot ◽  
Jacques Moret ◽  
Xavier Barreau ◽  
Istvan Szikora ◽  
Denis Herbreteau ◽  
...  
Keyword(s):  
Good Clinical Practice ◽  
Anterior Communicating Artery ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Patients Âgés ◽  
Link Type ◽  
Grade Scale ◽  
Aneurysm Occlusion ◽  
The Moment ◽  
The Web

BackgroundFlow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy.PurposeTo report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2.MethodsWEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.ResultsThe cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%.ConclusionsThis series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment.Clinical trial registrationFrench Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).

scholarly journals Competing Risks in Patients with Primary Prevention Implantable Cardioverters Defibrillators: Global Electrical Heterogeneity and Clinical Outcomes (GEHCO) Study

2020 ◽  
Author(s):  
Jonathan W. Waks ◽  
Kazi T. Haq ◽  
Christine Tompkins ◽  
Albert J. Rogers ◽  
Ashkan Ehdaie ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Systolic Heart Failure ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Ventricular Ejection Fraction ◽  
Hazard Functions ◽  
Risk Of Death ◽  
Link Type

AbstractBackgroundGlobal electrical heterogeneity (GEH) is associated with sudden cardiac death in the general population.ObjectiveTo investigate whether GEH is associated with sustained ventricular tachycardia (VT)/ventricular fibrillation (VF) leading to appropriate implantable cardioverter-defibrillator (ICD) therapies in systolic heart failure (HF) patients with primary prevention ICDs.MethodsWe conducted a multicenter retrospective cohort study. GEH was measured by spatial ventricular gradient (SVG) direction and magnitude, QRS-T angle, and sum absolute QRST integral (SAIQRST) on pre-implant 12-lead ECGs. Survival analysis using cause-specific hazard functions compared the strength of associations with two competing outcomes: sustained VT/VF leading to appropriate ICD therapies and all-cause death without appropriate ICD therapies.ResultsWe analyzed data from 2,668 patients (age 63±12y; 23% female; 78% white; 43% nonischemic cardiomyopathy (NICM); left ventricular ejection fraction 28±11% from 6 academic medical centers). After adjustment for demographic, clinical, device, and traditional ECG characteristics, SVG elevation (Hazard Ratio (HR) per 1 standard deviation (SD) 1.14 (95% CI 1.04-1.25); P=0.004), SVG azimuth (HR 1.12(1.01-1.24); P=0.039); SVG magnitude (HR per 1 SD 0.75 (0.66-0.85); P<0.0001), and QRS-T angle (HR per 1 SD 1.21 (95% CI 1.08-1.36); P=0.001) were associated with appropriate ICD therapies. The SVG azimuth was also associated with a lower competing risk of death (Pdifference=0.007): HR 0.91(0.82-1.02); P=0.095. SAIQRST had different associations in ischemic [HR 1.29(1.04-1.60)] and NICM [HR 0.78(0.62-0.96); Pinteraction=0.022].ConclusionIn patients with primary prevention ICDs, GEH is independently associated with appropriate ICD therapies. The SVG vector points in distinctly different directions in patients with two competing outcomes.Clinical Trial RegistrationURL:www.clinicaltrials.gov Unique identifier: NCT03210883.

Safety and Effectiveness of the Pipeline Flex Embolization Device With Shield Technology for the Treatment of Intracranial Aneurysms: Midterm Results From a Multicenter Study

Neurosurgery ◽  
2019 ◽  
Vol 87 (1) ◽  
pp. 104-111 ◽  
Author(s):  
Felipe Padovani Trivelato ◽  
Eduardo Wajnberg ◽  
Marco Túlio Salles Rezende ◽  
Alexandre Cordeiro Ulhôa ◽  
Ronie Leo Piske ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Intracranial Aneurysms ◽  
First Generation ◽  
Case Series ◽  
Neurological Complications ◽  
Total Occlusion ◽  
Safety Endpoint ◽  
Long Term Follow Up ◽  
Ischemic Complications ◽  
Large Case Series

Abstract BACKGROUND The safety and efficacy of the first generation of the Pipeline Embolization Device (PED; Medtronic Inc) have been proven in large case series. Ischemic events are one of the most common complications following treatment of aneurysms with flow diverters. The new PED Flex with Shield technology (PED Shield; Medtronic Inc) was introduced to minimize the rate of complications. OBJECTIVE To evaluate the outcomes of patients harboring aneurysms treated with the PED Shield. METHODS This was an observational, prospective, single-arm multicenter study of patients treated with the PED Shield. The primary safety endpoint was the absence of major neurological complications and death. The secondary effectiveness endpoint was angiographic occlusion at 6 and 12 mo. Technical complications were also reported. RESULTS Between November 2017 and December 2018, 151 patients from 7 centers with 182 aneurysms were enrolled. The mean aneurysm size was 7.0 mm; 27 (14.8%) aneurysms were large, and 7 (3.8%) were giant. In 141 of 151 patients (93.4%), the primary endpoint was reached. The overall rate of periprocedural complications was 7.3%. Of the aneurysms, 79.7% met the study's secondary endpoint of complete occlusion at 6 mo and 85.3% at 12 mo. CONCLUSION The PED Shield is a safe and effective treatment for intracranial aneurysms. The results regarding total occlusion and ischemic complications did not differ from those obtained in case series using previous versions of the PED. Long-term follow-up and comparative studies are required to provide stronger conclusions regarding the reduced thrombogenicity of this device.

Sign in / Sign up

Export Citation Format

Share Document