CAROTID REVASCULARIZATION ENDARTERECTOMY VS STENTING

颈动脉血运重建术与支架置入术

• 批准号: 7127555
• 负责人: ROBERT W HOBSON
• 金额: $ 15.55万
• 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/7127555
• 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===========================================

超出提供的空间。支架辅助颈动脉经皮血管成形术(SACPTA)是一种较新的手术方法，近年来得到了越来越多的应用。它的增长至少在一定程度上是由于对颅外颈动脉闭塞性疾病进行侵入性较小的治疗所带来的优势。然而，对SACPTA和颈动脉内膜切除术(CEA)的疗效进行对比的数据尚不清楚，CEA是治疗颈动脉粥样硬化的金标准。目前的报告要么是非随机对照，要么是回顾性临床研究。颈动脉内膜切除术与支架试验(CREST)比较了SACPTA和CEA在30天的围手术期或同侧卒中持续四年的随访期内预防中风、心肌梗死或死亡的有效性。中风事件将由蒙面接受指定治疗的裁决委员会进行核实。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)和术后(30天后)的发病率和死亡率(3)估计和对比两种手术的再狭窄率，(4)评估与健康相关的生活质量和成本效益指标的差异，(5)确定SACPTA和CEA具有不同风险的参与者亚组，主要的资格标准是短暂性脑缺血发作或同侧非致残性中风患者的颈动脉高度狭窄。男性和女性将有资格参加试验，但有可能限制他们在后续行动中参与或干扰结果评估的医疗条件的患者将被排除在外。在认证和培训阶段之后，2200名患者将被随机分配到治疗中。对主要结果的统计分析将使用标准的生存技术，并将导致90%的力量来检测主要结果事件发生率为？1.2%的组之间的年度差异。表演网站========================================Section End===========================================