Recruiting

WEB

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT03936647

Conditions

Intracranial Aneurysm

Brain Aneurysm

Unruptured Cerebral Aneurysm

Ruptured Cerebral Aneurysm

Cerebral Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling

WEB embolization device

Study Details

Brief summary:

Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.

Conditions

Intracranial Aneurysm

Brain Aneurysm

Unruptured Cerebral Aneurysm

Ruptured Cerebral Aneurysm

Cerebral Aneurysm

Study ID

NCT03936647

Start date

Jul 18, 2019

Status verified date

Aug, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patient with an intracranial aneurysm in whom WEB is considered an appropriate therapeutic option by the participating clinician
  • aneurysm of maximum diameter of 4-11 mm
  • may include (but are not restricted to) saccular bifurcation aneurysms of the middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery aneurysms
  • Recurring, persistent aneurysm after previous treatment can be included so long as the treating physician judges the aneurysm morphology to be appropriate.
  • Ruptured aneurysms with WFNS ≤ 3

Exclusion Criteria:

  • Absolute contraindication to surgery, endovascular treatment or anesthesia
  • Patients unable to give informed consent
  • diameter of the aneurysm ≤ 4 mm but ≥ 11 mm
  • Ruptured aneurysms with WFNS 4 or 5

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard conventional treatment (surgical or endovascular)

Treatment may include the most appropriate amongst surgical clipping, simple coiling, high-porosity stenting with or without coiling, and intra-arterial flow diversion with or without coiling, which will be predetermined by the treating physician prior to randomization.

experimental: WEB embolization device

Endovascular treatment with WEB, including standard management of thrombo-embolic risk

Interventions

surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling

Treatment may include the most appropriate amongst surgical clipping, simple coiling, high-porosity stenting with or without coiling, and intra-arterial flow diversion with or without coiling, which will be predetermined by the treating physician prior to randomization.

WEB embolization device

WEB embolization device

Primary outcome measure

  • Number of participants with imaging showing that index aneurysm has reached complete or near occlusion [ Time Frame: 1 year from procedure ]
  • Number of patients with a modified Rankin Score (mRS) below or equal to 2 [ Time Frame: 1 year from procedure ]

Central Contacts and Locations

Central contacts

daniela E Iancu, MD

514-890-8450daniela.iancu.med@ssss.gouv.qc.ca

Guylaine Gevry, BSc

514-890-8000guylaine.gevry.chum@ssss.gouv.qc.ca

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Tim E Darsaut, MD

tdarsaut@ualberta.ca

Principal Investigator:

Tim E Darsaut, MD

University of Manitoba Hospital

Recruiting

Winnipeg, Manitoba, Canada, R3E 3P5

Contacts

Susan Alcock, RN, MN

204-789-3996susan.alcock@umanitoba.ca

Principal Investigator:

Jai Jay Shiva Shankar, MD

Hamilton Health Sciences - McMaster University

Recruiting

Hamilton, Ontario, Canada

Contacts

Amanda Martyniuk, MSc

(905) 521-2100martynia@mcmaster.ca

Principal Investigator:

Brian van Adel, MD

Centre Hospitalier de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada, H2X 0C1

Contacts

Guylaine Gevry, BSc

514-890-8000guylaine.gevry.chum@ssss.gouv.qc.ca

Ruby Klink, PhD

514-890-8000Ruby.Klink@crchum.qc.ca

Principal Investigator:

Daniel Roy, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 15, 2024

Last verified

Aug, 2024

Keywords

  • intracranial aneurysm
  • cerebral aneurysm
  • brain aneurysm
  • unruptured cerebral aneurysm
  • ruptured cerebral aneurysm
  • WEB embolization device
  • embolization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-08-15.