NCT03936647 The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
| NCT ID | NCT03936647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Intracranial Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2019-07-18 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2019-07-18 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03936647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03936647 currently recruiting?
Yes, NCT03936647 is actively recruiting participants. Contact the research team at daniela.iancu.med@ssss.gouv.qc.ca for enrollment information.
Where is the NCT03936647 trial being conducted?
This trial is being conducted at Edmonton, Canada, Winnipeg, Canada, Hamilton, Canada, Montreal, Canada.
Who is sponsoring the NCT03936647 clinical trial?
NCT03936647 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 250 participants.