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The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices

Study acronym: RISE
StatusUnknown
PhaseNot applicable
Started2019-07-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 15, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2024-08-13
minor
Study Status, Contacts/Locations v7
Trial statusRecruiting→Unknown
Study sites1→4
2023-07-04
minor
Study Status v6
Primary completion date2023-07→2025-01
Completion date2024-07→2026-01
2022-11-14
minor
2 amendments v4-v5
2 re-verifications since 2021-07-26, no change to tracked fields
2020-04-16
minor
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
Show 2 earlier versions
2019-11-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-06→confirmed 2019-07-18
Study sitesdetails revised at 1 of 1 site
2019-05-30
minor
Study Identification, Study Status v1
Primary completion date2023-05→2023-07
Completion date2024-05→2024-07
Start date2019-05→2019-06
Study title+1 characters
The iWEBRISE Trial: IntroductionA toRandomized theTrial WEBon Intra-Saccular AneurysmEndobridge DeviceDevices
2019-05-01
minor
Original filing
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.
Trial Details
NCT Number NCT03936647
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm, Cerebral Aneurysm
Enrollment 250 participants
Start Date 2019-07-18
Primary Completion 2025-01 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-15