Comparing treatments for wide-necked brain aneurysms using the WEB device
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
This study is testing whether a new device called the WEB can help treat wide-necked brain aneurysms better than traditional surgery or other standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 4 sites (Edmonton, Alberta and 3 other locations) |
| Trial ID | NCT03936647 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of the WEB (Woven EndoBridge) device for treating wide-necked bifurcation aneurysms compared to traditional surgical and endovascular techniques. Patients with intracranial aneurysms deemed suitable for the WEB device will be randomly assigned to receive either the WEB treatment or other standard interventions. The study aims to determine which approach yields the best outcomes for patients with these challenging aneurysms. By focusing on a specific subset of aneurysms, the trial seeks to provide clearer guidance on optimal treatment options.
Who should consider this trial
Good fit: Ideal candidates include patients with intracranial aneurysms between 4-11 mm in diameter who are considered suitable for the WEB device.
Not a fit: Patients with aneurysms smaller than 4 mm or larger than 11 mm, or those with severe ruptured aneurysms, may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved treatment outcomes for patients with wide-necked brain aneurysms.
How similar studies have performed: While the WEB device has shown promise in preliminary studies, this trial is essential to establish its effectiveness compared to existing treatment methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta and 3 other locations
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
- University of Manitoba Hospital — Winnipeg, Manitoba, Canada (Recruiting)
- Hamilton Health Sciences - McMaster University — Hamilton, Ontario, Canada (Recruiting)
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: daniela E Iancu, MD
- Email: daniela.iancu.med@ssss.gouv.qc.ca
- Phone: 514-890-8450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.