The WEB®-IT China Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-21

Study Completion Date

2021-04-30

Brief Summary

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This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.

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Detailed Description

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Conditions

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Wide Neck Bifurcation Intracranial Aneurysms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

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WEB Aneurysm Embolization Device

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. Subjects will be screened for study eligibility after giving informed consent.

Group Type EXPERIMENTAL

WEB Aneurysm Embolization

Intervention Type DEVICE

Subjects will be screened for study eligibility after giving informed consent. The WEB embolization procedure will be performed in the catheterization room using standard angiographic techniques.

Interventions

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WEB Aneurysm Embolization

Subjects will be screened for study eligibility after giving informed consent. The WEB embolization procedure will be performed in the catheterization room using standard angiographic techniques.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient whose age ≥ 18 and ≤75 years old
* Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment
* Patient must sign and date IRB/EC approved written informed consent prior to initiate 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No