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

NCT ID: NCT03379714

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-01-31

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.

Conditions

Ruptured and Unruptured Intracranial Aneurysms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with ruptured or unruptured intracranial aneurysms

WEB aneurysm embolization system

Intervention Type: DEVICE

The WEB aneurysm embolization system is a class III device and consists of an implantable embolization device attached to a delivery device. The WEB is a mesh composed of single layers of braided nitinol tubes with platinum cores. The braids are held together by proximal and distal platinum/ iridium radiopaque markers.

Interventions

WEB aneurysm embolization system

The WEB aneurysm embolization system is a class III device and consists of an implantable embolization device attached to a delivery device. The WEB is a mesh composed of single layers of braided nitinol tubes with platinum cores. The braids are held together by proximal and distal platinum/ iridium radiopaque markers.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is at least 18 years old.

2. Patient is capable to undergo general anaesthesia.

3. Patient must sign and date the informed consent form 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.

4. Patient has a ruptured or unruptured intracranial aneurysm requiring endovascular treatment.

5. Aneurysm with dome-to-neck ratio ≥ 1.

6. Aneurysm size favourable for WEB implantation (aneurysm width < 10 mm or aneurysm width > 3mm).

Exclusion Criteria

1. Patient is pregnant.

2. Patient has renal insufficiency (GRF < 45 ml/min/1.73 m2).

3. Patient is unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Archer Research

INDUSTRY

Sponsor Role: collaborator

Medical Therapy Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurits Voormolen, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

University Hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

MTS-02

Identifier Type: -

Identifier Source: org_study_id