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

NCT01976026 | Withdrawn

• 1 other identifier: CE13.114
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months following treatment

• 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.

  at last follow-up (1 year following treatment, +/- 1 month)

Secondary Outcomes (10)

• Modified Rankin Scale score

  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

  within 24 hours after procedure, if appropriate

• Peri-operative complications

  Within one month of treatment

• Angiographic outcome

  between 3-12 months following treatment

• Number of days of hospitalization

  Within a month following procedure

Study Arms (2)

Endovascular treatment with flow diversion

EXPERIMENTAL

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.

Device: Flow Diversion

Best standard therapy

ACTIVE COMPARATOR

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.

Device: Best Standard Therapy

Interventions

Flow Diversion DEVICE

Endovascular treatment with flow diversion

Best Standard Therapy DEVICE

Also known as: 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).

Best standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Aneurysm; Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean Raymond, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 5, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

CA (1)