The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · May 1, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The RISE Trial is a research study looking at a new treatment option for patients with certain types of brain aneurysms, specifically wide-necked bifurcation aneurysms. These are challenging to treat using traditional methods. The study is testing the WEB (Woven EndoBridge), a device that helps close off the aneurysm without needing patients to take blood-thinning medications. Researchers want to find out if this new device leads to better outcomes for patients compared to existing treatments.
To participate in the trial, patients should be between 65 and 74 years old and have a specific type of unruptured or ruptured brain aneurysm that falls within a certain size range (4-11 mm in diameter). Eligible participants will be those whose doctors believe the WEB is a suitable treatment option. If you join the trial, you will receive care and monitoring while researchers collect information to see how well the WEB device works. This study is currently recruiting participants, and it aims to provide valuable insights into the best ways to treat these complex aneurysms.
Gender
ALL
Eligibility criteria
- 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
About Centre Hospitalier De L'université De Montréal (Chum)
The Centre Hospitalier de l'Université de Montréal (CHUM) is a leading academic health institution in Canada, dedicated to advancing patient care through innovative research and clinical excellence. As a prominent sponsor of clinical trials, CHUM is committed to leveraging its multidisciplinary expertise and state-of-the-art facilities to facilitate groundbreaking studies that enhance medical knowledge and improve health outcomes. Collaborating with a network of healthcare professionals and researchers, CHUM fosters a rigorous research environment that prioritizes patient safety, ethical standards, and scientific integrity, positioning itself at the forefront of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Edmonton, Alberta, Canada
Montréal, Quebec, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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