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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-18

Study Completion Date

2026-01-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard conventional treatment (surgical or endovascular)

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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.

WEB embolization device

Endovascular treatment with WEB, including standard management of thrombo-embolic risk

Group Type EXPERIMENTAL

WEB embolization device

Intervention Type DEVICE

WEB embolization device

Interventions

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

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.

Intervention Type PROCEDURE

WEB embolization device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No