SWISS-PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- mRS score
研究概览
简要总结
We hypothesize that patients with a favorable Critical Area Perfusion Score (CAPS≤3) on cerebral perfusion imaging will have a favorable response to revascularization by thrombectomy and that patients with a CAPS>3 will not
详细描述
PRECISE is a multicenter, prospective, observational cohort study. SWISS-PRECISE is a Switzerland Based spin-off of PRECISE with the intention to perform a final pooled analysis of data.
All procedures correspond to standard care and clinical routine. Perfusion imaging will be acquired prior to thrombectomy treatment. Enrolled patients have undergone standard of care baseline imaging with CT or MRI that includes angiography and cerebral perfusion imaging; therefore will be performed a control-MRI (or CT scan) after 24 hours and/or within 5±1 days from the thrombectomy, or before discharge.
Study procedures include the standard of care clinical follow-up assessments at uniform time intervals (5±1 days or discharge, 30±7 days, and 90±14 days). Data that will be collected on participants include: (1) all brain imaging; (2) demographics; (3) limited history; (4) blood pressure and vital signs before, during and after thrombectomy treatment; (5) NIHSS before and after thrombectomy treatment, at hospital discharge and at days 30 and 90 (if conducted in person); (6) discharge disposition; (7) modified Rankin Scale score prior to stroke, at discharge, and at days 30 and 90 (mRS will be assessed either in person or by phone); and (8) Quality of Life Assessment at day 90.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs and symptoms consistent with an acute posterior circulation ischemic stroke
- •Baseline modified Rankin Scale (mRS) score ≤2 prior to qualifying stroke
- •Subjects age is 18-89 years, 90 or more if fully independent
- •Baseline National Institutes of Health Stroke Scale Score >4 and remains >4 immediately prior to thrombectomy treatment
- •Stroke symptoms began within 48 hours of thrombectomy treatment. Stroke onset is defined as the time the patient was last known to be at his/her neurologic baseline. Wake-up strokes are eligible if they meet the above time limits.
- •Endovascular thrombectomy for BAO or PC-LVO planned as standard-of-care therapy (included aspiration, thrombectomy, angioplasty, stent placement, intravenous intrarterial GPIIb-IIIa inhibitor infusion)
- •Time of arterial puncture (femoral or radial artery) occurred (or expected to occur) within 120 minutes of CT or MR imaging study completion
- •Patient or Legally Authorized Representative has signed the study Informed Consent form
排除标准
- •Symptomatic stroke in another vascular territory (ie - MCA or ACA)
- •Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months
- •Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional outcomes evaluation
- •Any condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject Imaging
- •Acute symptomatic arterial occlusions in more than one vascular territory on CTA (ie - associated anterior circulation LVO of the internal, middle, or anterior cerebral artery).
- •Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm or arteriovenous malformation
- •Mass effect with significant herniation above the cerebral tentorium or below the foramen magnum
- •Intracranial stent implanted in the same vascular territory that precludes safe deployment/removal of neurothrombectomy device.
结局指标
主要结局
mRS score
时间窗: 5±1 days or discharge, 30±7 days, and 90±14 days
Ordinal distribution of modified Rankin Scale (mRS) Scores 90 days after thrombectomy treatment
次要结局
未报告次要终点
研究者
Dr. med. Carlo Cereda
PD Dr med.
Ospedale Civico, Lugano