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
- 1
- 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
- •Have the capacity to understand and sign an informed consent or have a Legally Authorized Representative that can understand and sign an informed consent prior to initial arteriotomy access.
- •Age ≥ 60 years of age at the time of signing the informed consent and/or randomization.
- •Significant ST-elevation myocardial infarction or left bundle branch block (LBBB) on ECG with chest pain < 12 hours.
- •Accessible right or left radial artery conduit for PCI.
- •Physician intent to perform trans-radial PCI.
- •Willing to be contacted at 1 year by the DCRI Call Center
- •Study Randomization Inclusion Criteria
- •To be eligible for randomization in the 'IRA only vs. Complete Revascularization' phase of this trial, subjects must meet all of the above criteria and all of the following criteria subsequent to arterial access:
- •Subject eligible for DES implantation.
- •Angiographic multi-vessel CAD determined by local visual estimation.
排除标准
- •Patient that have known medical conditions that would prevent or interrupt the recommended post procedure DES treatment regimen.
- •Patients that have known medical conditions that would prevent catheterization through the radial artery.
- •Patients that have known medical conditions that increase patient's risk above standard when using IFR.
- •Has had a cerebrovascular accident or transient ischemic neurological attack within the past 6 months.
- •Known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol.
- •Any condition associated with a life expectancy of less than 1 year.
- •Participation in another clinical study using an investigational agent or device within the past 3 months.
- •Study Randomization Exclusion Criteria If a subject who has been consented into the SAFE STEMI study develops or is found to have any of the following, they will not be eligible for randomization to an iFR guided complete revascularization vs. IRA-only primary PCI and will be excluded from the study.
- •Shock requiring pressors or mechanical circulatory assist support (IABP, Impella, ECMO, etc.) significant chronic renal disease (eGFR < 30) and/or on dialysis.
- •Other angiographic exclusions:
- •Single vessel CAD
- •Unprotected left main coronary artery disease
- •One or more major coronary distributions with CTO or indeterminate IRA
- •Clinical circumstances, which, in the judgment of the operator, preclude randomization.
研究组 & 干预措施
Single Vessel Disease
Standard of care comparator for those subjects with single vessel coronary artery disease. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Single Vessel Disease (Device)
Single Vessel Disease
Standard of care comparator for those subjects with single vessel coronary artery disease. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Medtronic Resolute family of stents (Device)
Single Vessel Disease
Standard of care comparator for those subjects with single vessel coronary artery disease. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Terumo Glidesheath Slender (Device)
Single Vessel Disease
Standard of care comparator for those subjects with single vessel coronary artery disease. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Terumo TR Band Radial Compression Device (Device)
Multi-vessel Disease, Culprit Vessel Only
Subjects randomized to revascularization of infarct related artery only. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Multi-vessel Disease, Culprit Vessel Only (Procedure)
Multi-vessel Disease, Culprit Vessel Only
Subjects randomized to revascularization of infarct related artery only. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Medtronic Resolute family of stents (Device)
Multi-vessel Disease, Culprit Vessel Only
Subjects randomized to revascularization of infarct related artery only. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Terumo Glidesheath Slender (Device)
Multi-vessel Disease, Culprit Vessel Only
Subjects randomized to revascularization of infarct related artery only. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Terumo TR Band Radial Compression Device (Device)
Multi-vessel Disease, Complete Revascularization
Subjects randomized to complete revascularization. Complete revascularization of all diseased arteries with Medtronic Resolute family of stents; Use of Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology to determine which arteries to stent; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Multi-vessel Disease, Complete Revascularization (Procedure)
Multi-vessel Disease, Complete Revascularization
Subjects randomized to complete revascularization. Complete revascularization of all diseased arteries with Medtronic Resolute family of stents; Use of Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology to determine which arteries to stent; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Medtronic Resolute family of stents (Device)
Multi-vessel Disease, Complete Revascularization
Subjects randomized to complete revascularization. Complete revascularization of all diseased arteries with Medtronic Resolute family of stents; Use of Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology to determine which arteries to stent; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology (Device)
Multi-vessel Disease, Complete Revascularization
Subjects randomized to complete revascularization. Complete revascularization of all diseased arteries with Medtronic Resolute family of stents; Use of Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology to determine which arteries to stent; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Terumo Glidesheath Slender (Device)
Multi-vessel Disease, Complete Revascularization
Subjects randomized to complete revascularization. Complete revascularization of all diseased arteries with Medtronic Resolute family of stents; Use of Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology to determine which arteries to stent; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
干预措施: Terumo TR Band Radial Compression Device (Device)
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)
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
时间窗: During procedure
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 Death (All Causes)(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)
- 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)
- 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 Cardiac Death (All Causes)(Day 31 to 1 year)
- Adjudicated Nonfatal (re-) MI(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)
- Incidence Rate of Access Success(During procedure)
- Adjudicated Stroke(Baseline to 30 days)
- Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)(Baseline to 30 days)
- Adjudicated Cardiac Death (All Causes)(Baseline to 30 days)
- Adjudicated Death (All Causes)(Baseline to 30 days)
- Adjudicated Cardiac Death(Baseline to 30 days)
- Adjudicated Index Infarct Related Vessel (re-) MI(Baseline to 30 days)
- Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)(Baseline to 30 days)
- Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)(Baseline to 30 days)
- Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis(Post-Procedure (0-24 hours post stent))
- Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis(30 days (>24 hours through 30 days post stent))
- Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis(Post-procedure (0-24hr post stent))
- Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis(30 days (>24hr to 30 days post stent))
- Adjudicated Stroke(Post-procedure)
研究者
David Kong, M.D.
Study Principal Investigator
Duke University