Overview

The recruitment status of this trial is unknown because the information has not been verified recently.

Condition ruptured aneurysm of intracranial artery
Treatments flow diversion, best standard therapy
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Start date November 2013
End date October 2016
Trial size 0 participants
Trial identifier NCT01976026, CE13.114

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
flow diversion
(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.
best standard therapy Best standard therapy, which may be any of the following:

Primary Outcomes

Measure
Neurological status of the patient
time frame: 3 months following treatment
Neurological status of the patient
time frame: at last follow-up (1 year following treatment, +/- 1 month)

Secondary Outcomes

Measure
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
Angiographic outcome
time frame: between 3-12 months following treatment
Number of days of hospitalization
time frame: Within a month following procedure
Discharge disposition/location
time frame: within a month following procedure
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
Re-treatment of the index aneurysm
time frame: Within one year following treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Jean Raymond, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM).