Comparison of Solitaire to Embotrap to Treat Large Vessel Occlusion in Acute Ischemic Stroke (SOLTRAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- Severity of Disability
研究概览
简要总结
The primary aim of this study is to assess if there is a difference in first pass reperfusion between the two devices. This is a randomized prospective study to assess if there is a difference in first pass reperfusion at two centers with large mechanical thrombectomy volumes. Data will also be collected on time-to treatment, outcomes and hemorrhagic complications.
详细描述
The SOLTRAP Study is an investigator initiated two hospital study designed to assess the procedural success and clinical outcomes associated with mechanical thrombectomy using the Medtronic Solitaire Device and the Cerenovous Embotrap device. Both devices are FDA approved for this indication of removal of a thrombus for patients suffering from stroke secondary to a large vessel occlusion.
Data collected will include device used during the procedure, mechanical thrombectomy techniques, time from onset to imaging, imaging to puncture, and overall time from onset to reperfusion as well as quality of life at 90 days post stroke.
The study will enroll up to 418 subjects and will be conducted at Wellstar North Fulton Hospital and Wellstar Kennestone Hospital. The devices will have regulatory authorization to be on the market in the geographic location of both sites.
The duration of the Registry protocol is approximately 24 months
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature
- •Occlusion of intracranial cerebral circulation vessel involving the M1, M2 MCA or ICA-T (Tandem occlusions will be enrolled)
- •Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 72 hours post-procedure
- •Subject is willing to comply with the protocol follow-up requirements
- •The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions for Use (IFU).
排除标准
- •1.The subject can participate in another clinical trial if the study does not impact the endpoints defined in this protocol given this is a data collection trial. Patients who are unable to comply wit the 90 day follow up in person or via telephone will be excluded from the study.
结局指标
主要结局
Severity of Disability
时间窗: Day 90 (+14)
assessed by mRS with a good functional outcome defined as mRS of 0-2 for each technique
次要结局
- Excellent functional outcome(Day 90 (+14))
研究者
Benjamin Zussman, MD
Comparison of Solitaire to Embotrap to treat Large Vessel Occlusion in Acute Ischemic stroke (SOLTRAP Study)
WellStar Health System