Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)

Not Applicable

Terminated

Conditions: Myocardial Infarction

Interventions: Procedure: Multi-vessel Disease, Culprit Vessel Only
Device: Single Vessel Disease
Procedure: Multi-vessel Disease, Complete Revascularization
Device: Medtronic Resolute family of stents
Device: Terumo Glidesheath Slender
Device: Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology
Device: Terumo TR Band Radial Compression Device

Registration Number: NCT02939976

Lead Sponsor: David Kong, M.D.

Brief Summary: 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.

Detailed Description: 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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 427

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Vessel Disease	Medtronic Resolute family of stents	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
Multi-vessel Disease, Culprit Vessel Only	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
Multi-vessel Disease, Culprit Vessel Only	Terumo Glidesheath Slender	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
Single Vessel Disease	Terumo Glidesheath Slender	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
Multi-vessel Disease, Culprit Vessel Only	Medtronic Resolute family of stents	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
Multi-vessel Disease, Complete Revascularization	Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology	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
Single Vessel Disease	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
Multi-vessel Disease, Complete Revascularization	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
Single Vessel Disease	Terumo TR Band Radial Compression Device	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
Multi-vessel Disease, Culprit Vessel Only	Terumo TR Band Radial Compression Device	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
Multi-vessel Disease, Complete Revascularization	Terumo TR Band Radial Compression Device	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
Multi-vessel Disease, Complete Revascularization	Medtronic Resolute family of stents	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
Multi-vessel Disease, Complete Revascularization	Terumo Glidesheath Slender	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

Primary Outcome Measures

Name	Time	Method
Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE)	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	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)	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)

Secondary Outcome Measures

Name	Time	Method
Adjudicated Death (All Causes)	Day 31 to 1 year
Adjudicated Nonfatal (re-) MI	Day 31 to 1 year	Efficacy endpoint
Adjudicated Index Infarct Related Vessel (re-) MI	Day 31 to 1 year	Efficacy endpoint
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)	Day 31 to 1 year	Efficacy endpoint
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)	Day 31 to 1 year	Efficacy endpoint
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis	1 year (>30 days post stent)	Safety endpoint
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis	1 year (>30 days post stent)	Safety endpoint
Adjudicated Stroke	Day 31 to 1 year
Adjudicated Cardiac Death (All Causes)	Day 31 to 1 year
Incidence Rate of Access Success	During procedure	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
Adjudicated Cardiac Death	Day 31 to 1 year	Efficacy endpoint
Adjudicated Nonfatal (re-) MI Myocardial (Infarction)	Baseline to 30 days	Efficacy endpoint
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	Secondary Observational Endpoint
Site Reported Time to Achieve Hemostasis	Post-procedure	Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed
Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed	During procedure