Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device

Microvention-Terumo, Inc.29 sites in 1 country180 target enrollmentAugust 24, 2022

ConditionsWide Neck Bifurcation Intracranial Aneurysms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wide Neck Bifurcation Intracranial Aneurysms
Sponsor: Microvention-Terumo, Inc.
Enrollment: 180
Locations: 29
Primary Endpoint: Key Effectiveness Outcome
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Registry

clinicaltrials.gov

Start Date

August 24, 2022

End Date

December 2029

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Microvention-Terumo, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient must be ≥ 18 at the time of screening
•Patient must have a single ruptured or unruptured IA requiring treatment
•Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures

Exclusion Criteria

•Patient has an IA with characteristics unsuitable for endovascular treatment
•Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
•Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
•Patient index IA was previously treated
•Patient is pregnant

Outcomes

Primary Outcomes

Key Effectiveness Outcome

Time Frame: 12 Months

Proportion of subjects with adequate aneurysm occlusion at one year after treatment.

Key Safety Outcome

Time Frame: 12 Months

Proportion of subjects with death of any nonaccidental cause or any major stroke\* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment