Ruptured Aneurysm of Intracranial Artery Clinical Trial
— DIVERTOfficial 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
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Centre Hospitalier de l'Université de Montréal | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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) | Yes |
| Secondary | Modified Rankin Scale score | within a month following treatment, and at 3 and 12 months post-treatment | Yes | |
| Secondary | Successful PED FD deployment/aneurysm clip-ligation/aneurysm coiling, with patency of parent arteries | within 24 hours after procedure, if appropriate | No | |
| Secondary | Peri-operative complications | Peri-operative complications (ischemic strokes and intracranial hemorrhages), defined as any severe adverse effect. | Within one month of treatment | Yes |
| Secondary | Angiographic outcome | Angiographic outcome (invasive or non-invasive imaging) (last observation carried forward) | between 3-12 months following treatment | No |
| Secondary | Number of days of hospitalization | Within a month following procedure | No | |
| Secondary | Discharge disposition/location | home; other hospital; rehabilitation facility; death | within a month following procedure | No |
| Secondary | Any new stroke, neurological symptom or sign | during follow-up (between discharge and 1 year post-treatment) | Yes | |
| Secondary | Hospital re-admission | from initial discharge to one year following treatment | No | |
| Secondary | Hemorrhagic complications | Hemorrhagic complications, in any body system, related to antiplatelet medication or not. | within one year following treatment | Yes |
| Secondary | Re-treatment of the index aneurysm | Within one year following treatment | No |