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

NCT03312725 | Terminated

• 1 other identifier: MTS-01
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA

  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

  at 6 months follow-up

• Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA

  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

  at 24 months follow-up

Secondary Outcomes (11)

• Determination of procedural complications (Adverse events) during the operation

  During index-procedure

• Recording the use of additional devices during treatment to occlude the aneurysm

  During index-procedure

• 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 6 to 8 weeks follow-up

• 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

Study Arms (1)

Patients with ruptured or unruptured intracranial aneurysms.

Device: WEB aneurysm embolization system

Interventions

WEB aneurysm embolization system 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.

Patients with ruptured or unruptured intracranial aneurysms.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ruptured or unruptured intracranial aneurysms.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Therapy Solutions: lead
• Archer Research: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Luc Defreyne

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 18, 2017
• Study Start: February 1, 2017
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: October 10, 2018

Record last verified: 2017-10

Locations

BE (1)