Status:
RECRUITING
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Wide Neck Bifurcation Intracranial Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
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 pri...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04839705
Start Date
August 24 2022
End Date
December 1 2029
Last Update
June 17 2025
Active Locations (29)
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1
Memorial Health Systems
Hollywood, Florida, United States, 33021
2
Orlando Health Neuroscience Institute
Orlando, Florida, United States, 32806
3
The Queen's Medical Center Neuroscience Institute
Honolulu, Hawaii, United States, 96813
4
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242