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）： 接受药物治疗（抗血栓治疗、风险因素调整）的颅内狭窄患者在狭窄动脉区域发生卒中的风险较高。这一发现，加上微导管、球囊和支架技术的最新进展，导致考虑将颅内支架植入术作为这些患者的替代治疗。 之前的一项多中心I期试验（SSYLVIA）评价了症状性颅内狭窄患者的裸金属支架，结果表明支架植入术可以安全地进行，技术成功率较高，但6个月再狭窄率较高，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可能有效的可能性，脑血管可能特别容易发生再狭窄。目前的研究是一项I期试验，将评价与使用药物洗脱支架（CYPHER TM，Cordis Neurovascular，Inc.）相关的安全性、性能、6个月再狭窄率和1年结局。65例主要颅内动脉（MCA、颈动脉、基底动脉、椎动脉）症状性狭窄50% - 99%的患者。所有患者将在支架植入术后随访1年，并在整个随访期间接受阿司匹林325 mg/天，在支架植入术后90天接受氯吡格雷。 将在入组研究时以及支架植入术后24小时、3个月、6个月、9个月和12个月对所有研究患者进行定期评价。所有患者将在支架植入后6个月进行单血管脑血管造影，以评价是否存在再狭窄。主要终点是支架植入后30天内的所有卒中和死亡。次要终点包括6个月时的再狭窄（> 50%）、12个月内治疗动脉区域的缺血性卒中、12个月内死亡、12个月内非致命性心肌梗死、12个月内严重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III期试验铺平道路，比较支架植入联合药物治疗与单独药物治疗对这种疾病的影响。