Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Composite primary endpoint:
研究概览
简要总结
Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia
详细描述
Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia
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
- None
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
- •localization and structure of the aneurysm allows the use of a DERIVO®/DERIVO® mini flow-diverting stent for treatment;
- •the aneurysm cannot be cured by other methods of endovascular therapy, or there is a higher risk of complications when using other methods of endovascular therapy or microsurgery;
- •clipping or embolization with spirals (if performed earlier) led to a recurrence of the aneurysm.
排除标准
- •Age less than 18 years.
- •The presence of a previously implanted stent in a cerebral artery.
- •Dissection of cerebral or peripheral vessels.
- •The presence of contraindications to the use of the DERIVO®/DERIVO® mini medical device, specified in the instructions for use:
- •non-compliance of the aneurysm and/or the carrier vessel with the indications for the use of the device;
- •non-physiological structure of cerebral vessels;
- •vascular disorders that are a contraindication to endovascular interventions.
- •The presence of contraindications for antiplatelet (antithrombotic) and/or anticoagulant therapy in accordance with the instructions for the medical use of drugs.
研究组 & 干预措施
Antiplatelet (antithrombotic) monotherapy
Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
干预措施: ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). (Drug)
Double antiplatelet (antithrombotic) therapy
Double antiplatelet (antithrombotic) therapy (DAT), including a combination of clopidogrel (tablets, 75 mg) and acetylsalicylic acid (ASA, tablets, 100 mg) or a combination of ticagrelor (tablets, 180 mg) and ASA (tablets, 100 mg).
干预措施: combination of clopidogrel (tablets, 75 mg) and acetylsalicylic acid (ASA, tablets, 100 mg) or a combination of ticagrelor (tablets, 180 mg) and ASA (tablets, 100 mg). (Drug)
结局指标
主要结局
Composite primary endpoint:
时间窗: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
The proportion of favorable clinical outcomes corresponding to 0-2 points on the modified Rankin Scale (mRS) for assessing clinical status in the medium-term (3-6 months) and long-term (12-18 months) postoperative period.
次要结局
- Secondary endpoints:(baseline/discharge)
研究者
Andrey Evgenievich Petrov
MD, Principal Investigator, Head of Neurosurgical Department
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health