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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04839705

Acronym

WEB PAS

Enrollment

195

Registered

2021-04-09

Start date

2022-08-24

Completion date

2030-05-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wide Neck Bifurcation Intracranial Aneurysms

Keywords

Aneurysm, Intracranial Arterial Disease, Cerebrovascular Disorders

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.

Interventions

DEVICEWEB

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Key Effectiveness Outcome	12 Months	Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Key Safety Outcome	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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid Fiorella, MD

Stony Brook University, Stony Brook NY

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026