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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Wide Neck Bifurcation Intracranial Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Health Systems, Hollywood, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 IRN 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 other intracranial hemorrhage within 90 days
Patient index IA was previously treated
Patient is pregnant

Treatment and study plan

WEB

Device

Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

Other Names:

WEB Aneurysm Embolization Device

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

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

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

Acronym: WEB PAS

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2030
First posted: Apr 9, 2021
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed