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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Neurological status of the patient
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Neurological status of the patient
时间窗: at last follow-up (1 year following treatment, +/- 1 month)
Neurological status graded according to the Rankin scale, defined as mRS\>2, from any disease, treatment or other related causes.
次要结局
- Angiographic outcome(between 3-12 months following treatment)
- Any new stroke, neurological symptom or sign(during follow-up (between discharge and 1 year post-treatment))
- Hemorrhagic complications(within one year following treatment)
- Hospital re-admission(from initial discharge to one year following treatment)
- 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)
- Discharge disposition/location(within a month following procedure)
- Re-treatment of the index aneurysm(Within one year following treatment)
- Peri-operative complications(Within one month of treatment)
- Number of days of hospitalization(Within a month following procedure)