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

Wide Neck Bifurcation Intracranial Aneurysms Clinical Trial

— WEB PAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839705
• Other study ID #: CL11010-001
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2022
• Est. completion date: December 2029

Study information

• Verified date: November 2022
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Wide Neck Bifurcation Intracranial Aneurysms

Intervention

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

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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