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

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction
• Intervention / Treatment: Device: Single Vessel Disease; Device: Medtronic Resolute family of stents; Device: Terumo Glidesheath Slender; Device: Terumo TR Band Radial Compression Device; Procedure: Multi-vessel Disease, Culprit Vessel Only; Procedure: Multi-vessel Disease, Complete Revascularization; Device: Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology

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

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27715
      • Duke Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. 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.
2. Age ≥ 60 years of age at the time of signing the informed consent and/or randomization.
3. Significant ST-elevation myocardial infarction or left bundle branch block (LBBB) on ECG with chest pain < 12 hours.
4. Accessible right or left radial artery conduit for PCI.
5. Physician intent to perform trans-radial PCI.
6. 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:

1. Subject eligible for DES implantation.
2. Angiographic multi-vessel CAD determined by local visual estimation.

Exclusion Criteria

1. Patient that have known medical conditions that would prevent or interrupt the recommended post procedure DES treatment regimen.
2. Patients that have known medical conditions that would prevent catheterization through the radial artery.
3. Patients that have known medical conditions that increase patient's risk above standard when using IFR.
4. Has had a cerebrovascular accident or transient ischemic neurological attack within the past 6 months.
5. Known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol.
6. Any condition associated with a life expectancy of less than 1 year.
7. 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.

1. Shock requiring pressors or mechanical circulatory assist support (IABP, Impella, ECMO, etc.) significant chronic renal disease (eGFR < 30) and/or on dialysis.

2. Other angiographic exclusions:

   • Single vessel CAD
   • Unprotected left main coronary artery disease
   • One or more major coronary distributions with CTO or indeterminate IRA
3. Clinical circumstances, which, in the judgment of the operator, preclude randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: Single Vessel 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; Device: Medtronic Resolute family of stents; Revascularization with Medtronic Resolute family of stents in infarct related artery; Device: Terumo Glidesheath Slender; Possible use of Terumo Glidesheath Slender; Device: Terumo TR Band Radial Compression Device; Possible use of Terumo TR Band Radial Compression Device
Experimental: 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	Device: Medtronic Resolute family of stents; Revascularization with Medtronic Resolute family of stents in infarct related artery; Device: Terumo Glidesheath Slender; Possible use of Terumo Glidesheath Slender; Device: Terumo TR Band Radial Compression Device; Possible use of Terumo TR Band Radial Compression Device; Procedure: Multi-vessel Disease, Culprit Vessel 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
Experimental: 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	Device: Medtronic Resolute family of stents; Revascularization with Medtronic Resolute family of stents in infarct related artery; Device: Terumo Glidesheath Slender; Possible use of Terumo Glidesheath Slender; Device: Terumo TR Band Radial Compression Device; Possible use of Terumo TR Band Radial Compression Device; Procedure: Multi-vessel Disease, Complete Revascularization; Complete revascularization of all diseased arteries; Device: Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology; Complete revascularization of all diseased arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Adjudicated 1-year Complete versus Lesion-only Primary PCI trial (CvLPRIT) 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.	1 year
Primary Observational Endpoint - Estimate of the incidence rate of Radial Artery Occlusion (RAO)	Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)	During procedure
Primary Observational Endpoint - Estimate of the incidence rate of Radial Artery Occlusion (RAO)	Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated Death (all causes)	Efficacy endpoint	Day 1
Adjudicated Death (all causes)	Efficacy endpoint	30 days
Adjudicated Death (all causes)	Efficacy endpoint	1 year
Adjudicated Cardiac Death	Efficacy endpoint	Day 1
Adjudicated Cardiac Death	Efficacy endpoint	30 days
Adjudicated Cardiac Death	Efficacy endpoint	1 year
Adjudicated Nonfatal (re-) MI	Efficacy endpoint	30 days
Adjudicated Nonfatal (re-) MI	Efficacy endpoint	1 year
Adjudicated Index Infarct Related vessel (re-) MI	Efficacy endpoint	30 days
Adjudicated Index Infarct Related vessel (re-) MI	Efficacy endpoint	1 year
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (ischemia driven)	Efficacy endpoint	30 days
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (ischemia driven)	Efficacy endpoint	1 year
Adjudicated Index Infarct Vessel Revascularization (IIVR) (ischemia driven)	Efficacy endpoint	30 days
Adjudicated Index Infarct Vessel Revascularization (IIVR) (ischemia driven)	Efficacy endpoint	1 year
Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis	Safety endpoint	Post-Procedure
Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis	Safety endpoint	30 days
Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis	Safety endpoint	1 year
Adjudicated Academic Research Consortium (ARC) definite stent thrombosis	Safety endpoint	Post-procedure
Adjudicated Academic Research Consortium (ARC) definite stent thrombosis	Safety endpoint	30 days
Adjudicated Academic Research Consortium (ARC) definite stent thrombosis	Safety endpoint	1 year
Adjudicated stroke		Post-procedure
Adjudicated stroke		30 days
Adjudicated stroke		1 year
Adjudicated Infarct Related vessel (re-P2) MI		Day 1
Adjudicated Infarct Related vessel (re-P2) MI		30 days
Heart failure (requiring hospitalization or 12 hour ER visit)		Day 1
Heart failure (requiring hospitalization or 12 hour ER visit)		30 days
Heart failure (requiring hospitalization or 12 hour ER visit)		1 year
Ischemia-driven revascularization for index infarct vessel revascularization (IIVR) or any treated index non-infarct related vessels (INIVR)		1 year
iFR guided revascularization - Site reported index hospitalization bleeding and vascular complication defined as bleeding or vascular co		During procedure
iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - total procedure time		During procedure
iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - total contrast used		During procedure
iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - occurrence of renal insufficiency		48-72 hours post-procedure
iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - occurrence of renal insufficiency		30 days
Terumo TR Band - Site reported time to achieve hemostasis	Secondary Observational Endpoint	Post-procedure
Terumo TR Band - Incidence rate of cross over from the initial access point to another stratified by whether or not Terumo Slender GlideSheath was employed (use of the GlideSheath Slender is recommended not required)	Secondary Observational Endpoint	Day 1
Terumo TR Band - Incidence rate of Access success defined as successfully deploying the stent through the right or left radial artery stratified by whether or not Terumo GlideSheath Slender was employed	Secondary Observational Endpoint	Day 1
Terumo TR Band - incidence of RAO, stratified by whether or not the Terumo TR Band was employed in combination with GlideSheath Slender	Secondary Observational Endpoint	Day 1
Terumo TR Band - incidence of RAO, stratified by whether or not the Terumo TR Band was employed in combination with GlideSheath Slender	Secondary Observational Endpoint	30 days
Medtronic Resolute® Family of Stents - Site determination of Device success	Device performance endpoint	During index procedure
Medtronic Resolute® Family of Stents - Site determination of Lesion success	Device performance endpoint	During index procedure
Medtronic Resolute® Family of Stents - • Site determination of Procedure success	Device performance endpoint	During index procedure in-hospitalization

Collaborators and Investigators

• Sponsor: David Kong, M.D.
• Collaborators: Medtronic Vascular; Terumo Medical Corporation; Volcano Corporation
• Investigators: Principal Investigator: David F Kong, MD, Duke University; Study Chair: Mitchell W Krucoff, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): July 19, 2023

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimated): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ST-Elevation Myocardial Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: Pro00076262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes