A Feasibility Trial to Evaluate the MindFrame System in the Recanalization of Occluded Vessels in Patients Experiencing an Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.
研究概览
简要总结
The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.
详细描述
The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NIHSS 6 to 30 within 6 hours of symptom onset
- •Pre-stroke Modified Rankin Score ≤ 2
- •Large Vessel Occlusion
- •Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.
- •Patients must meet at least one of the following criteria:
- •Eligible for Intravenous rt-PA
- •Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset
- •Patient presents within 6 hours of symptom onset
排除标准
- •Glucose <50mg/dL
- •Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0
- •Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
- •Patient has baseline platelets < 30,000
- •Evidence of rapidly improving neurological signs of stroke at time of enrollment
- •Pre-existing neurological or psychiatric disease that could confound the study results
- •Known severe allergy to contrast media or nitinol
- •Patient has severe sustained hypertension
- •CT/MRI scan reveals significant mass effect with midline shift
- •Patient's angiogram shows an arterial stenosis >50% proximal to the embolus.
- •Patient's anticipated life expectancy is less than 3 months
- •Participation in another clinical investigation that could confound the evaluation of the study device
结局指标
主要结局
Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.
时间窗: Immediately postprocedure
TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.
时间窗: Immediately postprocedure
TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Clinical Success
时间窗: 90 days postprocedure
Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.
次要结局
- Number of Device-related Serious Adverse Events(Treatment to 90 days postprocedure)