Clinical trial NCT03936647: The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Official title: The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Brain Aneurysm
Unruptured Cerebral Aneurysm
Ruptured Cerebral Aneurysm
Cerebral Aneurysm
Keywords: intracranial aneurysm
cerebral aneurysm
brain aneurysm
unruptured cerebral aneurysm
ruptured cerebral aneurysm
WEB embolization device
embolization
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with imaging showing that index aneurysm has reached complete or near occlusion
timeFrame: 1 year from procedure
measure: Number of patients with a modified Rankin Score (mRS) below or equal to 2
timeFrame: 1 year from procedure
Secondary outcomes:
measure: Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2
timeFrame: within 1 week post-procedure, 1-3 months, and 12 months post-treatment
measure: Number of successful deployment of WEB device, coils or successful microsurgical, clipping, along with judgement of patency of parent arteries using imaging (depending on treatment received)
timeFrame: within 1 hour from procedure
measure: Number of incidences of successful or unsuccesful patency of parent arteries using imaging
timeFrame: within 1 hour from procedure
measure: Number of peri-operative complications
timeFrame: ≥5 days
measure: Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging
timeFrame: 12 +/- 2 months
measure: Hospitalization time
timeFrame: up to first post-procedure visit (around 1 month)
measure: Incidence of discharge destination by type
timeFrame: up to first post-procedure visit (around 1 month)
measure: Number of participants with stroke, neurological symptom or sign
timeFrame: within 12 +/- 2 months
measure: Number of index aneurysms necessitating or having received retreatment due to re-occurence
timeFrame: Within 12 +/- 2 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - McMaster University
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References: