CAROTID REVASCULARIZATION ENDARTERECTOMY VS STENTING

颈动脉血运重建术与支架置入术

• 批准号: 7077792
• 负责人: ROBERT W HOBSON
• 金额: $ 562.73万
• 依托单位: UNIV OF MED/DENT OF NJ-NJ MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-01-15 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7077792
• 关键词: atherosclerosis; blood vessel prosthesis; carotid artery; clinical research; clinical trials; disease /disorder prevention /control; endarterectomy; health care cost /financing; human morbidity; human mortality; human subject; human therapy evaluation; intraluminal angioplasty; myocardial infarction; quality of life; restenosis; stroke; transient ischemic attack

EXCEED THE SPACE PROVIDED. Stent assisted carotid percutaneous transluminal angioplasty (SACPTA) is a relatively new procedure that has been used increasingly in recent years. Its growth is due, at least in part, to the perceived advantages of a less invasive treatment for extracranial carotid occlusive disease. However, data contrasting the efficacy of SACPTA and carotid endarterectomy (CEA), the gold standard treatment for carotid atherosclerosis, are not available. Current reports are either non-randomizec comparisons, or retrospective clinical studies. The Carotid RevascularizationEndarterectomy versus Stent Trial (CREST) contrasts the-rtSlfe-flVte^fficacyof SACPTA with CEA in preventing stroke, myocardial infarction or death during a 30-day peri-procedural period, or ipsilateral stroke ove the follow-up period extending up to four years. Stroke events will be verified by an Adjudication Committee masked to the assigned treatment. Secondary outcomes include:(1) describe differential efficacy of SACPTA and CEA in men and women, (2) contrast peri-procedural (30-day) morbidity and post-procedural (after 30-days) morbidity and mortality (3 estimate and contrast the restenosis rates of the two procedures, (4) evaluate differences in measures of health related quality of life andcost effectiveness , and (5) identify subgroups of participants at differential risk for SACPTA and CEA The primary eligibility criterion is a high grade U70%) stenosis of the carotid artery in patients with transient ischemic attack or ipsilateral non-disabling stroke. Men and women will be eligible for the trial, but patients with medical conditions ikely to limit their participation during the follow-up or to interfere with outcome evaluation will be excluded. After a credentialing and training phase, 2,200 patients will be randomizedto the treatments. Statistical analysis of the primary outcome will employ standard survival techniques, and will result in 90% power to detect annual differences between groups of ^1.2% in event rates of the primary outcomes. PERFORMANCE SITE ========================================Section End===========================================

超出所提供的空间。 支架辅助颈动脉经皮腔内血管成形术（SACPTA）是一种相对较新的手术，近年来应用越来越多。它的增长是由于，至少部分是由于颅外颈动脉闭塞性疾病的微创治疗的优势。然而，没有对比SACPTA和颈动脉内膜切除术（CEA）（颈动脉粥样硬化的金标准治疗）疗效的数据。目前的报告要么是非随机比较，要么是回顾性临床研究。 颈动脉血管再通内膜切除术与支架试验（CREST）对比了SACPTA与CEA在围手术期30天内预防卒中、心肌梗死或死亡的有效性，或在长达4年的随访期内预防同侧卒中的有效性。卒中事件将由对分配的治疗设盲的裁定委员会进行验证。次要结果包括：（1）描述SACPTA和CEA在男性和女性中的不同疗效，（2）对比围手术期（30天）发病率和术后（30天后）发病率和死亡率，（3）估计和对比两种手术的再狭窄率，（4）评价健康相关生活质量和成本效益指标的差异，（5）识别SACPTA和CEA不同风险的参与者亚组。主要合格标准是短暂性脑缺血发作或同侧非致残性卒中患者颈动脉高度U 70%狭窄。男性和女性都有资格参加本试验，但患有可能限制其在随访期间参与或干扰结局评价的医学疾病的患者将被排除在外。经过资格认证和培训阶段，2,200名患者将被随机分配到治疗组。主要结局的统计分析将采用标准生存技术，并将产生90%的把握度来检测主要结局事件发生率的组间年差异≥ 1.2%。性能现场=