Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 427
- 试验地点
- 2
- 主要终点
- Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE)
研究概览
简要总结
Patients with partially blocked blood vessel(s) in their heart may need a medical procedure called "Percutaneous Coronary Intervention (PCI)" to open the narrowed blood vessel(s). The purpose of this study is to simultaneously address four potential advances in ST-Elevation Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are looking to see if these advances can improve the outcome for these patients.
- Opening the arteries with a Medtronic stent
- Radial access (from wrist) success with a Medtronic stent
- Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
- Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.
详细描述
Multicenter, randomized, open-label, unblinded, active and historical-controlled trial in which approximately 875 seniors undergoing urgent PCI from approximately 70 centers will be enrolled. All consented subjects will undergo attempted radial arterial access.
For DES (Drug Eluting Stent) eligible patients without randomization exclusion criteria and with multi-vessel disease identified during initial angiogram will be randomized by site in a ratio of 1:1 to IRA-only revascularization or iFR-guided complete revascularization. After randomization, subjects with stable TIMI-3 flow established in the IRA using the protocol specified treatment will proceed with the randomized procedure. Subjects in whom IRA reperfusion with TIMI-3 flow is not achieved will be treated according to clinical best practice standard of care independent of randomized procedure assignment and will not be considered protocol violations. These patients will be followed identically to all study patients.
After stent implantation, subjects will be contacted for follow-up at 30 days by the enrolling site and at 1 year by the DCRI Call Center.
Primary endpoint results will be reported after all subjects have completed 1 year (12 months) of clinical follow-up.
STEMI patients eligible for radial access:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE)
时间窗: 1 year
Defined as cardiac death, infarct artery target-vessel MI, or ischemia-driven index infarct related vessel revascularization (IIVR) by percutaneous or surgical methods.
Adjudicated 1-year Modified CvLPRIT (Complete Versus Lesion-only Primary PCI Trial) MACE
时间窗: 1 year
Defined as all-cause mortality, recurrent MI, heart failure (requiring hospitalization or 12 hour ER visit) or ischemia-driven revascularization for all treated arteries.
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
时间窗: 30 day
Primary Observational Endpoint - Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
次要结局
- Adjudicated Cardiac Death(Day 31 to 1 year)
- Adjudicated Nonfatal (re-) MI Myocardial (Infarction)(Baseline to 30 days)
- Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)(Day 31 to 1 year)
- Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR)(30 days)
- Incidence of RAO, Stratified by Whether or Not the Terumo TR Band Was Employed in Combination With GlideSheath Slender(30 days)
- Site Reported Time to Achieve Hemostasis(Post-procedure)
- Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed(During procedure)
- Adjudicated Nonfatal (re-) MI(Day 31 to 1 year)
- Adjudicated Death (All Causes)(Day 31 to 1 year)
- Adjudicated Index Infarct Related Vessel (re-) MI(Day 31 to 1 year)
- Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)(Day 31 to 1 year)
- Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)(Day 31 to 1 year)
- Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis(1 year (>30 days post stent))
- Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis(1 year (>30 days post stent))
- Adjudicated Stroke(Day 31 to 1 year)
- Adjudicated Cardiac Death (All Causes)(Day 31 to 1 year)
- Incidence Rate of Access Success(During procedure)
研究者
David Kong, M.D.
Study Principal Investigator
Duke University