An interventional study of Flow Diversion and Best Standard Therapy in Ruptured Aneurysm of Intracranial Artery, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-22.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and 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.
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.
29 studies on the registry are indexed under Aneurysm, Ruptured; 7 are open to participants now.
Browse Aneurysm, Ruptured studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Compared within Aneurysm, Ruptured, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aneurysm. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
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.
Time frame: 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.
Time frame: at last follow-up (1 year following treatment, +/- 1 month)
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
Peri-operative complications (ischemic strokes and intracranial hemorrhages), defined as any severe adverse effect.
Time frame: Within one month of treatment
Angiographic outcome
Angiographic outcome (invasive or non-invasive imaging) (last observation carried forward)
Time frame: between 3-12 months following treatment
Number of days of hospitalization
Time frame: Within a month following procedure
Discharge disposition/location
home; other hospital; rehabilitation facility; death
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
Hemorrhagic complications, in any body system, related to antiplatelet medication or not.
Time frame: within one year following treatment
Re-treatment of the index aneurysm
Time frame: Within one year following treatment
This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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