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. 1. Opening the arteries with a Medtronic stent 2. Radial access (from wrist) success with a Medtronic stent 3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires. 4. Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.
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: * DES Eligible with single vessel Coronary Artery Disease (CAD) will receive DES to IRA * DES Eligible with Multi-vessel CAD will randomize 1:1 to IRA-only revascularization or Instantaneous Wave Free Radio (iFR)-guided complete revascularization
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
427
Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
Complete revascularization of all diseased arteries
Revascularization with Medtronic Resolute family of stents in infarct related artery
Complete revascularization of all diseased arteries
Possible use of Terumo Glidesheath Slender
Possible use of Terumo TR Band Radial Compression Device
Duke Clinical Research Institute
Durham, North Carolina, United States
Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE)
Defined as cardiac death, infarct artery target-vessel MI, or ischemia-driven index infarct related vessel revascularization (IIVR) by percutaneous or surgical methods.
Time frame: 1 year
Adjudicated 1-year Modified CvLPRIT (Complete Versus Lesion-only Primary PCI Trial) MACE
Defined as all-cause mortality, recurrent MI, heart failure (requiring hospitalization or 12 hour ER visit) or ischemia-driven revascularization for all treated arteries.
Time frame: 1 year
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
Primary Observational Endpoint. Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
Time frame: During procedure
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
Primary Observational Endpoint - Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
Time frame: 30 day
Adjudicated Death (All Causes)
Efficacy endpoint
Time frame: Baseline to 30 days
Adjudicated Death (All Causes)
Efficacy endpoint
Time frame: Day 31 to 1 year
Adjudicated Cardiac Death
Efficacy endpoint
Time frame: Baseline to 30 days
Adjudicated Cardiac Death
Efficacy endpoint
Time frame: Day 31 to 1 year
Adjudicated Nonfatal (re-) MI Myocardial (Infarction)
Efficacy endpoint
Time frame: Baseline to 30 days
Adjudicated Nonfatal (re-) MI
Efficacy endpoint
Time frame: Day 31 to 1 year
Adjudicated Index Infarct Related Vessel (re-) MI
Efficacy endpoint
Time frame: Baseline to 30 days
Adjudicated Index Infarct Related Vessel (re-) MI
Efficacy endpoint
Time frame: Day 31 to 1 year
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
Efficacy endpoint
Time frame: Baseline to 30 days
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
Efficacy endpoint
Time frame: Day 31 to 1 year
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
Efficacy endpoint
Time frame: Baseline to 30 days
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
Efficacy endpoint
Time frame: Day 31 to 1 year
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Time frame: Post-Procedure (0-24 hours post stent)
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Time frame: 30 days (>24 hours through 30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Time frame: 1 year (>30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Time frame: Post-procedure (0-24hr post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Time frame: 30 days (>24hr to 30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Time frame: 1 year (>30 days post stent)
Adjudicated Stroke
Time frame: Post-procedure
Adjudicated Stroke
Time frame: Baseline to 30 days
Adjudicated Stroke
Time frame: Day 31 to 1 year
Adjudicated Death (All Causes)
Time frame: Baseline to 30 days
Adjudicated Death (All Causes)
Time frame: Day 31 to 1 year
Adjudicated Cardiac Death (All Causes)
Time frame: Baseline to 30 days
Adjudicated Cardiac Death (All Causes)
Time frame: Day 31 to 1 year
Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
Time frame: Baseline to 30 days
Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
Time frame: Day 31 to 1 year
Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR)
Time frame: 30 days
Incidence of RAO, Stratified by Whether or Not the Terumo TR Band Was Employed in Combination With GlideSheath Slender
Secondary Observational Endpoint
Time frame: 30 days
Site Reported Time to Achieve Hemostasis
Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed
Time frame: Post-procedure
Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed
Time frame: During procedure
Incidence Rate of Access Success
Access success is defined as successfully deploying the stent through the right or left radial artery stratified by whether or not Terumo Slender GlideSheath was employed
Time frame: During procedure
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