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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Number of participants with imaging showing that index aneurysm has reached complete or near occlusion

Secondary Outcome

 Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2

Condition

Intracranial Aneurysm

Intervention

surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling

Study Arms / Comparison Groups

 Standard conventional treatment (surgical or endovascular)
Description:  Treatment may include the most appropriate amongst surgical clipping, simple coiling, high-porosity stenting with or without coiling, and intra-arterial flow diversion with or without coiling, which will be predetermined by the treating physician prior to randomization.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

250

Start Date

July 18, 2019

Completion Date

July 2024

Primary Completion Date

July 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 514-890-8000, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03936647

Organization ID

2020-8330


Responsible Party

Principal Investigator

Study Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)


Study Sponsor

, , 


Verification Date

April 2020