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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)

Primary Purpose

Ruptured Aneurysm of Intracranial Artery

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Flow Diversion
Best Standard Therapy
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ruptured Aneurysm of Intracranial Artery focused on measuring Flow Diversion, Aneurysm, Intracranial, Cerebral, Vertebral, blood blister-like, ruptured aneurysm, Pipeline Flow Diversion, Pipeline Flow Diverter, Best-Standard Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  1. Severe allergy, intolerance or bleeding disorder that prohibit the use of Acetyl Salicylic Acid (ASA), clopidogrel or other platelet inhibitors
  2. Acute hydrocephalus or intracranial hematomas necessitating urgent ventricular drainage or surgical evacuation (patients may be recruited after these urgent interventions have been performed)
  3. Absolute contraindication to endovascular treatment or anesthesia.

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endovascular treatment with flow diversion

Best standard therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Neurological status of the patient
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
Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.

Secondary Outcome Measures

Modified Rankin Scale score
Successful PED FD deployment/aneurysm clip-ligation/aneurysm coiling, with patency of parent arteries
Peri-operative complications
Peri-operative complications (ischemic strokes and intracranial hemorrhages), defined as any severe adverse effect.
Angiographic outcome
Angiographic outcome (invasive or non-invasive imaging) (last observation carried forward)
Number of days of hospitalization
Discharge disposition/location
home; other hospital; rehabilitation facility; death
Any new stroke, neurological symptom or sign
Hospital re-admission
Hemorrhagic complications
Hemorrhagic complications, in any body system, related to antiplatelet medication or not.
Re-treatment of the index aneurysm

Full Information

First Posted
October 22, 2013
Last Updated
November 21, 2016
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT01976026
Brief Title
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
Acronym
DIVERT
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-Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Rare aneurysms. No patient enrolled at site.
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ruptured Aneurysm of Intracranial Artery
Keywords
Flow Diversion, Aneurysm, Intracranial, Cerebral, Vertebral, blood blister-like, ruptured aneurysm, Pipeline Flow Diversion, Pipeline Flow Diverter, Best-Standard Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovascular treatment with flow diversion
Arm Type
Experimental
Arm Description
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.
Arm Title
Best standard therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Flow Diversion
Intervention Type
Device
Intervention Name(s)
Best Standard Therapy
Other Intervention Name(s)
Best standard therapy, which may be any of the following:, B1. Conservative management when no surgical or endovascular treatment is considered possible or reasonable, B2. Conventional endovascular options including coiling with or without high-porosity stenting, and stent-in stent techniques, B3. Parent vessel occlusion, with or without bypass, B4. Surgical clipping or clip-wrapping (including parent vessel occlusion as a salvage procedure).
Primary Outcome Measure Information:
Title
Neurological status of the patient
Description
Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.
Time Frame
3 months following treatment
Title
Neurological status of the patient
Description
Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.
Time Frame
at last follow-up (1 year following treatment, +/- 1 month)
Secondary Outcome Measure Information:
Title
Modified Rankin Scale score
Time Frame
within a month following treatment, and at 3 and 12 months post-treatment
Title
Successful PED FD deployment/aneurysm clip-ligation/aneurysm coiling, with patency of parent arteries
Time Frame
within 24 hours after procedure, if appropriate
Title
Peri-operative complications
Description
Peri-operative complications (ischemic strokes and intracranial hemorrhages), defined as any severe adverse effect.
Time Frame
Within one month of treatment
Title
Angiographic outcome
Description
Angiographic outcome (invasive or non-invasive imaging) (last observation carried forward)
Time Frame
between 3-12 months following treatment
Title
Number of days of hospitalization
Time Frame
Within a month following procedure
Title
Discharge disposition/location
Description
home; other hospital; rehabilitation facility; death
Time Frame
within a month following procedure
Title
Any new stroke, neurological symptom or sign
Time Frame
during follow-up (between discharge and 1 year post-treatment)
Title
Hospital re-admission
Time Frame
from initial discharge to one year following treatment
Title
Hemorrhagic complications
Description
Hemorrhagic complications, in any body system, related to antiplatelet medication or not.
Time Frame
within one year following treatment
Title
Re-treatment of the index aneurysm
Time Frame
Within one year following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Raymond, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Learn more about this 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

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