Neuroscience

Recruiting

Baptist Health Lexington

Richard D Paulsen

Principal Investigator

Carol Steiden

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WEB-PAS: Post-market surveillance study to evaluate the long-term safety and effectiveness of the WEB device.
Description

WEB-PAS: 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.

Learn more at ClinicalTrials.gov.

Eligibility 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