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

Intracranial Aneurysm | Unruptured Cerebral Aneurysm | Cerebral Aneurysm | Brain Aneurysm | Ruptured Cerebral Aneurysm

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

Centre Hospitalier de l'Université de Montréal
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Guylaine Gevry, BSc

[email protected]
514-890-8000
Backup Contact

Ruby Klink, PhD

[email protected]
514-890-8000
Hamilton Health Sciences - McMaster University
Hamilton Health Sciences - McMaster University
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Amanda Martyniuk, MSc

[email protected]
(905) 521-2100
University of Alberta Hospital
University of Alberta Hospital
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Tim E Darsaut, MD

[email protected]
University of Manitoba Hospital
University of Manitoba Hospital
Winnipeg, Manitoba
Canada

Contact Study Team

Primary Contact

Susan Alcock, RN, MN

[email protected]
204-789-3996
Study Sponsored By
Centre hospitalier de l'Université de Montréal (CHUM)
Participants Required
More Information
Study ID: NCT03936647