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）：颅内狭窄患者接受药物治疗（抗栓治疗，危险因素调整），狭窄动脉区域卒中风险高。这一发现，再加上微导管、球囊和支架技术的最新进展，促使人们考虑颅内支架置入术作为这些患者的替代治疗方法。先前的一项多中心I期试验（SSYLVIA）评估了裸金属支架在症状性颅内狭窄患者中的应用，结果显示支架置入可以安全且技术成功率高，但6个月的再狭窄率很高，并且经常与复发性缺血相关。药物洗脱支架在冠状动脉循环中预防再狭窄的成功，提高了这些支架在脑血管中也有效的可能性，脑血管可能特别容易再狭窄。目前的研究是一项I期试验，将评估65例颅内主要动脉（MCA、颈动脉、基底动脉、椎动脉）50% - 99%症状性狭窄患者使用药物洗脱支架（CYPHER TM, Cordis Neurovascular, Inc.）的安全性、性能、6个月再狭窄率和1年预后。所有患者在支架置入术后随访1年，整个随访期间每天服用阿司匹林325 mg，支架置入术后90天服用氯吡格雷。所有研究患者将在研究开始时以及支架植入后24小时、3个月、6个月、9个月和12个月进行定期评估。所有患者在支架植入后6个月进行单血管脑血管造影以评估再狭窄的存在。主要终点是支架植入术后30天内所有中风和死亡。次要终点包括6个月时再狭窄（> 50%），12个月内治疗动脉区域缺血性卒中，12个月内死亡，12个月内非致死性心肌梗死，12个月内全身性大出血或颅内出血。该研究将：1)确定药物洗脱治疗颅内狭窄的安全性、性能和潜在疗效2)为比较支架植入联合药物治疗与单独药物治疗的III期试验铺平道路。