Clinical Trial: DIVERT: Diversion of Flow in Intracranial VErtebral and Blood Blister-like Ruptured Aneurysms Trial: A Randomized Trial Comparing Pipeline Flow Diversion and Best-Standard-Treatment

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Diversion of Flow in Intracranial VErtebral and Blood Blister-like Ruptured Aneurysms Trial Trial: A Randomized Trial Comparing Pipeline Flow Diversion and Best-Standard-T

Brief Summary: The purpose of the DIVERT study is to provide a prudent, controlled clinical context for the use of flow diversion, a promising option of yet unproven benefit, in the care of patients with acute blood blister-like and dissecting intradural aneurysms. Hence DIVERT is a simple, multicenter, randomized trial integrated into daily practice. DIVERT addresses the clinical dilemma of whether the use of PED FD truly is a safe and effective alternative to best standard treatment, defined as conventional methods of treatment or in some cases, observation. Selection criteria are few, to facilitate the recruitment of most affected patients confronted with these difficult aneurysms that their physician judges suitable for PED FD. The trial does not obstruct clinical care, does not include extra tests or risks beyond what is necessary and proven beneficial. Endpoints are simple, clinical, meaningful, valuable and resistant to bias. Follow-up visits and tests are "routine', imposing no extra burden on clinical transactions. Data is collected in simple case-report forms filled by physicians.

Detailed Summary:

Ruptured blood blister-like (BB) and dissecting vertebral aneurysms are infrequent but devastating causes of subarachnoid hemorrhage (SAH), prone to acute rebleeding with poor clinical outcomes despite current surgical or endovascular treatment. Flow diversion (PED FD) with the Pipeline Endovascular Device (PED) is a promising treatment alternative to conventional management options.

The DIVERT trial is designed to provide a prudent, controlled clinical framework for offering the PED FD , a promising yet unproven option in the care of patients with acute blood blister-like or dissecting vertebral aneurysms. DIVERT is a care trial, designed as a simple, pragmatic, multicenter, randomized trial integrated into daily practice with inclusive selection criteria.

The investigators hypothesize that PED FD can decrease poor outcomes from 30 to 15%, compared to 'best standard treatment' (BST). BST is chosen prior to randomization amongst 4 options: observation, coiling with or without stenting, parent vessel occlusion or surgical clipping or wrapping. Patients are enrolled within 48 hours of SAH using standard 1:1 randomization between PED FD and BST after informed consent has been obtained from the patient or surrogate decision maker(s). Patients for whom no other option than PED FD appears feasible and safe will be included in a registry conducted alongside the trial.

Blister-like aneurysms and intradural dissections presenting with SAH have a high propensity for rebleeding and outcomes are poor in approximately one third of the cases, despite treatment using surgical or endovascular techniques.


Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Current Primary Outcome:

  • Neurological status of the patient [ Time Frame: 3 months following treatment ]
    Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.
  • Neurological status of the patient [ Time Frame: at last follow-up (1 year following treatment, +/- 1 month) ]
    Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Modified Rankin Scale score [ Time Frame: within a month following treatment, and at 3 and 12 months post-treatment ]
  • Successful PED FD deployment/aneurysm clip-ligation/aneurysm coiling, with patency of parent arteries [ Time Frame: within 24 hours after procedure, if appropriate ]
  • Peri-operative complications [ Time Frame: Within one month of treatment ]
    Peri-operative complications (ischemic strokes and intracranial hemorrhages), defined as any severe adverse effect.
  • Angiographic outcome [ Time Frame: between 3-12 months following treatment ]
    Angiographic outcome (invasive or non-invasive imaging) (last observation carried forward)
  • Number of days of hospitalization [ Time Frame: Within a month following procedure ]
  • Discharge disposition/location [ Time Frame: within a month following procedure ]
    home; other hospital; rehabilitation facility; death
  • Any new stroke, neurological symptom or sign [ Time Frame: during follow-up (between discharge and 1 year post-treatment) ]
  • Hospital re-admission [ Time Frame: from initial discharge to one year following treatment ]
  • Hemorrhagic complications [ Time Frame: within one year following treatment ]
    Hemorrhagic complications, in any body system, related to antiplatelet medication or not.
  • Re-treatment of the index aneurysm [ Time Frame: Within one year following treatment ]


Original Secondary Outcome: Same as current

Information By: Centre hospitalier de l'Université de Montréal (CHUM)

Dates:
Date Received: October 22, 2013
Date Started: November 2013
Date Completion:
Last Updated: November 21, 2016
Last Verified: November 2016