Overview

This trial is active, not recruiting.

Conditions wide neck bifurcation intracranial aneurysms, intracranial aneurysms
Treatment web
Sponsor Sequent Medical, Inc
Start date August 2014
End date December 2020
Trial size 150 participants
Trial identifier NCT02191618, CP13-001

Summary

The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.
web WEB Aneurysm Embolization Device
The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

Primary Outcomes

Measure
Primary Safety Outcome
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Patient whose age ≥18 and ≤75 years. - Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment. - Patient must sign and date an IRB/EC-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 stroke-in-evolution within the prior 60 days - Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days - Patient's index IA was previously treated - Patient is pregnant

Additional Information

Official title The WEB® Intrasaccular Therapy Study (WEB-IT)
Principal investigator Adam Arthur, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Sequent Medical, Inc.