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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

200 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Key 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 IRB-approved written informed consent prior to initiation of any study procedures

Key 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 any other intracranial hemorrhage within 90 days
• Patient's index IA was previously treated
• Patient is pregnant

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (29)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

29 locations

Study team and timeline

Lead sponsor

Microvention-Terumo, Inc.

Study start

Aug 24, 2022 Actual

Primary completion

May 8, 2027 Estimated

Study completion

May 7, 2031 Estimated

First posted

Apr 9, 2021 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts