The CREST-2 Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Any stroke or death within 30 days after the stenting procedure.
研究概览
简要总结
The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists. Interventionists' eligibility will be determined by a multi-specialty Interventional Management Committee (IMC). Patient eligibility will include patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-procedural complications. The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure. The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial.
详细描述
Objectives:
- Promote the rapid initiation and completion of enrollment in CREST-2
- CAS will be performed by experienced operators
- Clinical outcomes will be closely monitored
- Prevent inappropriate use of CAS outside of the registry
Registry Data Collection:
The registry will leverage the existing data-collection infrastructure of the Society for Vascular Surgery's (SVS) Vascular Quality Initiative (VQI) and the American College of Cardiology's (ACC) National Cardiovascular Data Registry (NCDR). Both organizations have agreed to participate in this effort. The specific logistics of data-collection and transfer are:
- The interventionist must pick a registry, SVS VQI or ACC NCDR to enter data.
- The interventionist instructs their registry to transfer de-identified information about their cases to C2R.
- The cases are reviewed by the C2R Management Committee.
- Reports of the cases, including whether or not they are CREST-2 eligible, will be maintained. These reports will allow close monitoring of C2R interventionists.
- C2R Management Committee, and other parties (NINDS, CMS) will be informed of the progress periodically.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic patients:
- •Age ≥ 18 and ≤ 80 and any one of the following
- •≥70% stenosis, standard surgical risk for CEA
- •≥70% stenosis, high anatomic risk for CEA
- •≥70% stenosis, high physiologic risk for CEA
- •Symptomatic patients:
- •Symptomatic patients are defined by the following characteristics: Ipsilateral carotid Transient Ischemic Attack (TIA), with neurologic symptoms persisting less than 24 hours; Ipsilateral non-disabling stroke: Modified Rankin Scale (mRS) ≤ 3; and Ipsilateral transient monocular blindness: amaurosis fugax. [Source: current Medicare NCD for CAS]
- •Age ≥ 18 and ≤ 80 and any one of the following
- •≥50% stenosis, standard surgical risk for CEA
- •50% to 69% stenosis, high anatomic risk for CEA
- •50% to 69% stenosis, high physiologic risk
- •≥70% stenosis, high anatomic and/or physiologic risk for CEA - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
- •≥70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
- •≥70% stenosis, post-irradiation - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
排除标准
- •Patients with any one of the following conditions are ineligible for enrollment in C2R
- •NYHA Class IV CHF
- •COPD on chronic continuous oxygen therapy
- •Severe (Class Childs D) liver failure
- •End-stage renal failure requiring dialysis
- •Cancer with metastatic spread and/or undergoing active chemotherapeutic treatment
- •Any dementia considered greater than "mild"
研究组 & 干预措施
Carotid Artery Disease
Patients undergoing carotid artery stenting for high grade carotid artery stenosis with or without neurologic symptoms and with or without a high risk for carotid endarterectomy.
干预措施: Carotid Artery Stent (Device)
结局指标
主要结局
Any stroke or death within 30 days after the stenting procedure.
时间窗: 30 days
次要结局
未报告次要终点
研究者
Brajesh Lal
PI
University of Maryland, Baltimore