The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Recruiting now · Not applicable
Conditions studied: Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm, Cerebral Aneurysm
In brief
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.
Key facts
- Study ID
- NCT03936647
- Run by
- Centre hospitalier de l'Université de Montréal (CHUM)
- People needed
- 250
- Starts
- 2019-07-18
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2024-08-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
- University of Manitoba Hospital — Winnipeg, Manitoba, Canada (enrolling)
- Hamilton Health Sciences - McMaster University — Hamilton, Ontario, Canada (enrolling)
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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