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

NCT03379714 | Withdrawn

• 1 other identifier: MTS-02
• Study Type: observational
• Target: N/A
• 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

• 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

Secondary Outcomes (13)

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

  during index-procedure

• Recording the use of additional devices during treatment.

  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 baseline

• Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)

  at 6 to 8 weeks follow-up

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+
• 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 at least 18 years old.
• Patient is capable to undergo general anaesthesia.
• 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.
• Patient has a ruptured or unruptured intracranial aneurysm requiring endovascular treatment.
• Aneurysm with dome-to-neck ratio ≥ 1.
• Aneurysm size favourable for WEB implantation (aneurysm width \< 10 mm or aneurysm width \> 3mm).

You may not qualify if:

• Patient is pregnant.
• Patient has renal insufficiency (GRF \< 45 ml/min/1.73 m2).
• 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).

Sponsors & Collaborators

• Medical Therapy Solutions: lead
• Archer Research: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Maurits Voormolen, Prof Dr

  Study Principal Investigator

  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: December 13, 2017
• First Posted: December 20, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: June 1, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)