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

NCT02939976 | Terminated Results DMC FDA Device

• 1 other identifier: Pro00076262
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

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. 1.Opening the arteries with a Medtronic stent
2. 2.Radial access (from wrist) success with a Medtronic stent
3. 3.Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
4. 4.Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.

Conditions

Myocardial Infarction

Keywords

ST-Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (4)

• 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 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.

  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)

  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)

  30 day

Secondary Outcomes (32)

• Adjudicated Death (All Causes)

  Baseline to 30 days

• Adjudicated Death (All Causes)

  Day 31 to 1 year

• Adjudicated Cardiac Death

  Baseline to 30 days

• Adjudicated Cardiac Death

  Day 31 to 1 year

• Adjudicated Nonfatal (re-) MI Myocardial (Infarction)

  Baseline to 30 days

Other Outcomes (8)

• Medtronic Resolute® Family of Stents - Site Determination of Procedure Success

  During index procedure in-hospitalization

• Medtronic Resolute® Family of Stents - Site Determination of Lesion Success

  During index procedure

• Medtronic Resolute® Family of Stents - Site Determination of Device Success

  During index procedure

Study Arms (3)

Single Vessel Disease

ACTIVE COMPARATOR

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; Device: Medtronic Resolute family of stents; Device: Terumo Glidesheath Slender; Device: Terumo TR Band Radial Compression Device

Multi-vessel Disease, Culprit Vessel Only

EXPERIMENTAL

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

Procedure: Multi-vessel Disease, Culprit Vessel Only; Device: Medtronic Resolute family of stents; Device: Terumo Glidesheath Slender; Device: Terumo TR Band Radial Compression Device

Multi-vessel Disease, Complete Revascularization

EXPERIMENTAL

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

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

Interventions

Single Vessel Disease 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

Single Vessel Disease

Multi-vessel Disease, Culprit Vessel Only PROCEDURE

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, Complete Revascularization PROCEDURE

Complete revascularization of all diseased arteries

Multi-vessel Disease, Complete Revascularization

Medtronic Resolute family of stents DEVICE

Revascularization with Medtronic Resolute family of stents in infarct related artery

Multi-vessel Disease, Complete Revascularization; Multi-vessel Disease, Culprit Vessel Only; Single Vessel Disease

Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology DEVICE

Complete revascularization of all diseased arteries

Multi-vessel Disease, Complete Revascularization

Terumo Glidesheath Slender DEVICE

Possible use of Terumo Glidesheath Slender

Multi-vessel Disease, Complete Revascularization; Multi-vessel Disease, Culprit Vessel Only; Single Vessel Disease

Terumo TR Band Radial Compression Device DEVICE

Possible use of Terumo TR Band Radial Compression Device

Multi-vessel Disease, Complete Revascularization; Multi-vessel Disease, Culprit Vessel Only; Single Vessel Disease

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• David Kong, M.D.: lead
• Medtronic Vascular: collaborator
• Volcano Corporation: collaborator
• Terumo Medical Corporation: collaborator

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27715, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: David Kong, M.D.
• Organization: Duke University Medical Center

David.F.Kong@duke.edu

919-668-8946

Study Officials

• David F Kong, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Mitchell W Krucoff, MD

  Duke University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 20, 2016
• Study Start: August 30, 2017
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)