PRAISE Study

赞美研究

• 批准号: 6907488
• 负责人: MARC IVOR CHIMOWITZ
• 金额: $ 37.84万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-15 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6907488
• 关键词: artery occlusion; blood vessel prosthesis; cardiovascular disorder prevention; cerebrovascular surgery; clinical research; clinical trial phase I; human subject; human therapy evaluation; patient oriented research; postoperative complications; sirolimus; stroke

DESCRIPTION (provided by applicant): Patients with intracranial stenosis treated medically (antithrombotic therapy, risk factor modification) have a high risk of stroke in the territory of the stenotic artery. This finding, coupled with recent advances in micro catheter, balloon, and stent technology, has led to consideration of intracranial stenting as an alternative treatment for these patients. A previous multicenter Phase I trial (SSYLVIA) that evaluated a bare metal stent in patients with symptomatic intracranial stenosis showed that stenting could be performed safely and with high technical success, but the 6-month restenosis rate was high and was frequently associated with recurrent ischemia. The success of drug-eluting stents in the coronary circulation for preventing restenosis raises the possibility that these stents may also be effective in the cerebral vessels, which may be particularly susceptible to restenosis. The current study is a Phase I trial that will evaluate the safety, performance, 6-month restenosis rate, and 1-year outcome associated with the use of a drug-eluting stent (CYPHER TM , Cordis Neurovascular, Inc.) in 65 patients with symptomatic 50% - 99% stenosis of a major intracranial artery (MCA, carotid, basilar, vertebral). All patients will be followed for 1 year after stenting and will receive aspirin 325 mg per day for the entire follow-up period and clopidogrel for 90 days after stenting. Regular evaluations of all study patients will be performed at study entry and 24 hours, 3 months, 6 months, 9 months, and 12 months after stenting. A single vessel cerebral angiogram will be performed on all patients 6 months after stenting to evaluate the presence of restenosis. The primary endpoint is all stroke and death within 30 days of stenting. Secondary endpoints include restenosis (> 50%) at 6 months, ischemic stroke in the territory of the treated artery within 12 months, death within 12 months, non-fatal myocardial infarction within 12 months, major systemic hemorrhage or any intracranial hemorrhage within 12 months. This study will: i) determine the safety, performance, and potential efficacy of a drug-eluting for treating intracranial stenosis ii) pave the way for a Phase III trial comparing stenting combined with medical therapy vs. medical therapy alone for this disease.

描述（由申请人提供）：接受医学治疗的颅内狭窄患者（抗血栓疗法，风险因素修饰）在狭窄动脉领土的中风风险很高。这一发现，再加上微导导管，气球和支架技术的最新进展，导致考虑颅内支架作为这些患者的替代治疗方法。 以前的多中心I期试验（SSYLVIA）评估了有症状性颅内狭窄患者的裸金属支架，表明可以安全地进行支架，并且具有很高的技术成功，但是6个月的再狭窄率很高，并且经常与经常性缺血相关。 在冠状动脉循环中进行药物洗脱支架在预防再狭窄的成功增加了这些支架在大脑血管中也可能有效的可能性，这可能特别容易受到再狭窄。 The current study is a Phase I trial that will evaluate the safety, performance, 6-month restenosis rate, and 1-year outcome associated with the use of a drug-eluting stent (CYPHER TM , Cordis Neurovascular, Inc.) in 65 patients with symptomatic 50% - 99% stenosis of a major intracranial artery (MCA, carotid, basilar, vertebral).支架支架后，所有患者将在整个随访期间每天接受325毫克的阿司匹林和氯吡格雷，持续1年，支架支架后90天。 定期对所有研究患者进行定期评估，并在支架支架后24小时，3个月，6个月，9个月和12个月进行。支架后6个月后，将对所有患者进行单血管脑血管造影，以评估再狭窄的存在。主要终点是支架后30天内所有中风和死亡。次要终点包括6个月时再狭窄（> 50％），在治疗动脉的领土内的缺血性中风，在12个月内死亡，在12个月内的非致命性心肌梗塞，主要全身出血或任何颅内出血。这项研究将：i）确定药物洗脱治疗颅内狭窄的安全性，性能和潜在疗效ii）为第三期试验铺平了与单独的医疗疗法与仅针对这种疾病的医疗治疗相比，为此铺平了道路。