Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System

Terminated

• Conditions: Ruptured and Unruptured Intracranial Aneurysms
• Interventions: Device: WEB aneurysm embolization system

• Registration Number: NCT03312725
• Lead Sponsor: Medical Therapy Solutions

Brief Summary

Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will collect data about the routine practice in one center of using the WEB in ruptured and unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by assessing the anatomic outcome during follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-18
• Primary Completion: 2018-06-26
• Study Completion: 2018-06-26
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patient is between 18 and 80 years old.
• Patient must sign and date the informed consent form <72hrs post-procedure and prior to data registration. If patient is not able to give informed consent for himself/herself, a legally authorized representative must give informed consent on his/her behalf.
• Patient has a ruptured (Hunt and Hess grades 1, 2 or 3) or unruptured intracranial aneurysm requiring endovascular treatment.
• Aneurysm with dome-to-neck ratio ≥ 1.

Exclusion Criteria

• Aneurysm size unfavourable for WEB implantation (aneurysm width > 10 mm or aneurysm width < 3mm).
• Patient with Hunt and Hess grades 4 or 5.
• Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
• Parent vessel occlusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ruptured or unruptured intracranial aneurysms.	WEB aneurysm embolization system	-

Primary Outcome Measures

Name	Time	Method
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA	at 24 months follow-up	WEB Occlusion Scale: WOS A: complete occlusion WOS B: complete occlusion with opacification of the proximal recess WOS C: residual neck filling WOS D: residual aneurysm filling

Secondary Outcome Measures

Name	Time	Method
Recording the use of additional devices during treatment to occlude the aneurysm	During index-procedure	Possible additional devices are stent, coils, flow diverter
Recording of intracranial haemorrhage during follow-up	up to 24 months
Determination of 30 day mortality	up to 30 days
Determination of procedural complications (Adverse events) during the operation	During index-procedure	Procedural complications: aneurysm rupture, dissection, thromboembolic events (symptomatic and non-symptomatic), device protrusion through the neck of the aneurysm inside the parent artery, detachment problem, device stuck in microcatheter, bleeding.
Determination of the technical success of the device defined as device deployment in the target aneurysm as intended by the investigator with complete apposition against the aneurysm wall.	During index-procedure
Need for repeat treatment during follow-up	up to 24 months
Determination of the occurrence of post-procedural symptomatic thromboembolic events	up to 24 months follow-up
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)	at 24 months follow-up	0 - No symptoms.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.
Determination of overall mortality	up to 24 months

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium