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)
Ruptured Aneurysm of Intracranial Artery
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
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.
Sites / Locations
- Centre Hospitalier de l'Université de Montréal
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Endovascular treatment with flow diversion
Best standard therapy
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.