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NCT Number: NCT03936647

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

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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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Aneurysm Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Ruptured Cerebral Aneurysm Unruptured Cerebral Aneurysm Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Device

WEB embolization device

Primary outcomes

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

    Time frame: 1 year from procedure

    complete or near complete occlusion of the aneurysm

  2. Number of patients with a modified Rankin Score (mRS) below or equal to 2

    Time frame: 1 year from procedure

    mRS ≤2 from evaluation (questionnaire) at follow-up visits throughout study. Grading score is to be assessed as such: Grade 0 No symptoms at all. Grade 1 No significant disability despite symptoms; able to carry out all usual duties and activities Grade 2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Grade 3 Moderate disability; requiring some help, but able to walk without assistance Grade 4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Grade 5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention Grade 6 Dead

Secondary outcomes

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

    Time frame: within 1 week post-procedure, 1-3 months, and 12 months post-treatment

    mRS ≤2 from evaluation (questionnaire) at discharge and follow-up visits throughout study. Grading score is to be assessed as such: Grade 0 No symptoms at all. Grade 1 No significant disability despite symptoms; able to carry out all usual duties and activities Grade 2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Grade 3 Moderate disability; requiring some help, but able to walk without assistance Grade 4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Grade 5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention Grade 6 Dead

  2. 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)

    Time frame: within 1 hour from procedure

    Successful WEB deployment / aneurysm clipping / aneurysm coiling

  3. Number of incidences of successful or unsuccesful patency of parent arteries using imaging

    Time frame: within 1 hour from procedure

    Analysis of imaging to judge the patency of the parent arteries

  4. Number of peri-operative complications

    Time frame: ≥5 days

    Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)

  5. Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging

    Time frame: 12 +/- 2 months

    Angiographic outcome (invasive or non-invasive imaging) results

  6. Hospitalization time

    Time frame: up to first post-procedure visit (around 1 month)

    Hospital stay (number of days)

  7. Incidence of discharge destination by type

    Time frame: up to first post-procedure visit (around 1 month)

    Discharge disposition (home; other hospital; rehabilitation facility; death)

  8. Number of participants with stroke, neurological symptom or sign

    Time frame: within 12 +/- 2 months

    Any new stroke, neurological symptom or sign

  9. Number of index aneurysms necessitating or having received retreatment due to re-occurence

    Time frame: Within 12 +/- 2 months

    Re-treatment of the index aneurysm as judged by imaging and interventionists neurosurgeons due to incomplete occlusion or hemorrhage

Study contacts

Contact information is provided by the study sponsor or research team.

Guylaine Gevry, BSc

CONTACT

[email protected]

514-890-8000 ext. 27235

daniela E Iancu, MD

CONTACT

[email protected]

514-890-8450

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Acronym: RISE

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
May 3, 2019
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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