- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976026
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 (DIVERT)
Diversion of Flow in Intracranial VErtebral and Blood Blister-like Ruptured Aneurysms Trial Trial: A Randomized Trial Comparing Pipeline Flow Diversion and Best-Standard-Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Centre Hospitalier de l'Université de Montréal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A patient affected with a blood blister-like aneurysm or a dissecting aneurysm, vertebral or at other sites, responsible for a recent subarachnoid hemorrhage (<14 days) for whom PED FD is considered an appropriate therapeutic option by the participating clinician. Current indications may be (but not restricted to) symptomatic blister-like aneurysms and dissecting intradural vertebral aneurysms.
Exclusion Criteria:
- Severe allergy, intolerance or bleeding disorder that prohibit the use of Acetyl Salicylic Acid (ASA), clopidogrel or other platelet inhibitors
- Acute hydrocephalus or intracranial hematomas necessitating urgent ventricular drainage or surgical evacuation (patients may be recruited after these urgent interventions have been performed)
- Absolute contraindication to endovascular treatment or anesthesia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endovascular treatment with flow diversion
Endovascular treatment with flow diversion, including standard management of thrombo-embolic risk. The goal of the treatment procedure is (as usual) to prevent rebleeding, while keeping treatment-related risks as low as possible. This trial permits the interventionist or surgeon to use any device, technique or drug judged important to the safety and success of the endovascular or surgical procedure, at his/her discretion at any time during the procedure. It is imperative that the allocated procedure is conducted in the safest possible manner. The interventionist or surgeon may switch to an alternative BST or cross-over to the alternative treatment group, if it is in the best interest of the patient. |
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Active Comparator: Best standard therapy
May be any of the following: Conservative management when no surgical or endovascular treatment is considered possible or reasonable Conventional endovascular options including coiling with or without high-porosity stenting, and stent-in stent techniques Parent vessel occlusion, with or without bypass Surgical clipping or clip-wrapping (including parent vessel occlusion as a salvage procedure). Choice of best option is based on the location, anatomy, and particular circumstances, before randomization for this patient's aneurysm. This trial permits the interventionist or surgeon to use any device, technique or drug judged important to the safety and success of the endovascular or surgical procedure, at his/her discretion at any time during the procedure. The interventionist or surgeon may switch to an alternative BST or cross-over to the alternative treatment group, if it is in the best interest of the patient. |
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 months following treatment
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Neurological status of the patient
Time Frame: at last follow-up (1 year following treatment, +/- 1 month)
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Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.
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at last follow-up (1 year following treatment, +/- 1 month)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Rankin Scale score
Time Frame: within a month following treatment, and at 3 and 12 months post-treatment
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within a month following treatment, and at 3 and 12 months post-treatment
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Successful PED FD deployment/aneurysm clip-ligation/aneurysm coiling, with patency of parent arteries
Time Frame: within 24 hours after procedure, if appropriate
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within 24 hours after procedure, if appropriate
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Peri-operative complications
Time Frame: Within one month of treatment
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Peri-operative complications (ischemic strokes and intracranial hemorrhages), defined as any severe adverse effect.
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Within one month of treatment
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Angiographic outcome
Time Frame: between 3-12 months following treatment
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Angiographic outcome (invasive or non-invasive imaging) (last observation carried forward)
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between 3-12 months following treatment
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Number of days of hospitalization
Time Frame: Within a month following procedure
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Within a month following procedure
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Discharge disposition/location
Time Frame: within a month following procedure
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home; other hospital; rehabilitation facility; death
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within a month following procedure
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Any new stroke, neurological symptom or sign
Time Frame: during follow-up (between discharge and 1 year post-treatment)
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during follow-up (between discharge and 1 year post-treatment)
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Hospital re-admission
Time Frame: from initial discharge to one year following treatment
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from initial discharge to one year following treatment
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Hemorrhagic complications
Time Frame: within one year following treatment
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Hemorrhagic complications, in any body system, related to antiplatelet medication or not.
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within one year following treatment
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Re-treatment of the index aneurysm
Time Frame: Within one year following treatment
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Within one year following treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Jean Raymond, MD, Centre hospitalier de l'Université de Montréal (CHUM)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE13.114
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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