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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02939976
First Posted: October 20, 2016
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medtronic Vascular
Volcano Corporation
Terumo Medical Corporation
Information provided by (Responsible Party):
David Kong, M.D., Duke University Medical Center
  Purpose

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.

Condition Intervention
Myocardial Infarction Device: Single Vessel Disease Procedure: Multi-vessel Disease, Culprit Vessel Only 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)

Resource links provided by NLM:


Further study details as provided by David Kong, M.D., Duke University Medical Center:

Primary Outcome Measures:
  • Adjudicated 1-year infarct-related artery Major Adverse Cardiac and Cerebrovascular Event (MACE) [ Time Frame: 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 Complete versus Lesion-only Primary PCI trial (CvLPRIT) MACE [ Time Frame: 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.

  • Primary Observational Endpoint - Estimate of the incidence rate of Radial Artery Occlusion (RAO) [ Time Frame: During procedure ]
    Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)

  • Primary Observational Endpoint - Estimate of the incidence rate of Radial Artery Occlusion (RAO) [ Time Frame: 30 day ]
    Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)


Secondary Outcome Measures:
  • Adjudicated Death (all causes) [ Time Frame: Day 1 ]
    Efficacy endpoint

  • Adjudicated Death (all causes) [ Time Frame: 30 days ]
    Efficacy endpoint

  • Adjudicated Death (all causes) [ Time Frame: 1 year ]
    Efficacy endpoint

  • Adjudicated Cardiac Death [ Time Frame: Day 1 ]
    Efficacy endpoint

  • Adjudicated Cardiac Death [ Time Frame: 30 days ]
    Efficacy endpoint

  • Adjudicated Cardiac Death [ Time Frame: 1 year ]
    Efficacy endpoint

  • Adjudicated Nonfatal (re-) MI [ Time Frame: 30 days ]
    Efficacy endpoint

  • Adjudicated Nonfatal (re-) MI [ Time Frame: 1 year ]
    Efficacy endpoint

  • Adjudicated Index Infarct Related vessel (re-) MI [ Time Frame: 30 days ]
    Efficacy endpoint

  • Adjudicated Index Infarct Related vessel (re-) MI [ Time Frame: 1 year ]
    Efficacy endpoint

  • Adjudicated Index Infarct Related Lesion Revascularization (IILR) (ischemia driven) [ Time Frame: 30 days ]
    Efficacy endpoint

  • Adjudicated Index Infarct Related Lesion Revascularization (IILR) (ischemia driven) [ Time Frame: 1 year ]
    Efficacy endpoint

  • Adjudicated Index Infarct Vessel Revascularization (IIVR) (ischemia driven) [ Time Frame: 30 days ]
    Efficacy endpoint

  • Adjudicated Index Infarct Vessel Revascularization (IIVR) (ischemia driven) [ Time Frame: 1 year ]
    Efficacy endpoint

  • Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis [ Time Frame: Post-Procedure ]
    Safety endpoint

  • Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis [ Time Frame: 30 days ]
    Safety endpoint

  • Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis [ Time Frame: 1 year ]
    Safety endpoint

  • Adjudicated Academic Research Consortium (ARC) definite stent thrombosis [ Time Frame: Post-procedure ]
    Safety endpoint

  • Adjudicated Academic Research Consortium (ARC) definite stent thrombosis [ Time Frame: 30 days ]
    Safety endpoint

  • Adjudicated Academic Research Consortium (ARC) definite stent thrombosis [ Time Frame: 1 year ]
    Safety endpoint

  • Adjudicated stroke [ Time Frame: Post-procedure ]
  • Adjudicated stroke [ Time Frame: 30 days ]
  • Adjudicated stroke [ Time Frame: 1 year ]
  • Adjudicated Infarct Related vessel (re-P2) MI [ Time Frame: Day 1 ]
  • Adjudicated Infarct Related vessel (re-P2) MI [ Time Frame: 30 days ]
  • Heart failure (requiring hospitalization or 12 hour ER visit) [ Time Frame: Day 1 ]
  • Heart failure (requiring hospitalization or 12 hour ER visit) [ Time Frame: 30 days ]
  • Heart failure (requiring hospitalization or 12 hour ER visit) [ Time Frame: 1 year ]
  • Ischemia-driven revascularization for index infarct vessel revascularization (IIVR) or any treated index non-infarct related vessels (INIVR) [ Time Frame: 1 year ]
  • iFR guided revascularization - Site reported index hospitalization bleeding and vascular complication defined as bleeding or vascular co [ Time Frame: During procedure ]
  • iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - total procedure time [ Time Frame: During procedure ]
  • iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - total contrast used [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days ]
  • Terumo TR Band - Site reported time to achieve hemostasis [ Time Frame: Post-procedure ]
    Secondary Observational Endpoint

  • 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) [ Time Frame: Day 1 ]
    Secondary Observational Endpoint

  • 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 [ Time Frame: Day 1 ]
    Secondary Observational Endpoint

  • Terumo TR Band - incidence of RAO, stratified by whether or not the Terumo TR Band was employed in combination with GlideSheath Slender [ Time Frame: Day 1 ]
    Secondary Observational Endpoint

  • Terumo TR Band - incidence of RAO, stratified by whether or not the Terumo TR Band was employed in combination with GlideSheath Slender [ Time Frame: 30 days ]
    Secondary Observational Endpoint

  • Medtronic Resolute® Family of Stents - Site determination of Device success [ Time Frame: During index procedure ]
    Device performance endpoint

  • Medtronic Resolute® Family of Stents - Site determination of Lesion success [ Time Frame: During index procedure ]
    Device performance endpoint

  • Medtronic Resolute® Family of Stents - • Site determination of Procedure success [ Time Frame: During index procedure in-hospitalization ]
    Device performance endpoint


Estimated Enrollment: 875
Actual Study Start Date: August 30, 2017
Estimated Study Completion Date: March 30, 2021
Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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, 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
Procedure: Multi-vessel Disease, Complete Revascularization
Complete revascularization of all diseased arteries
Device: Medtronic Resolute family of stents
Revascularization with Medtronic Resolute family of stents in infarct related artery
Device: Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology
Complete revascularization of all diseased arteries
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

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 65 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. Patients with a known history of Coronary Artery Bypass Grafting (CABG).
  5. Has had a cerebrovascular accident or transient ischemic neurological attack within the past 6 months.
  6. Known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol.
  7. Any condition associated with a life expectancy of less than 1 year.
  8. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939976


Locations
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27715
Sponsors and Collaborators
David Kong, M.D.
Medtronic Vascular
Volcano Corporation
Terumo Medical Corporation
Investigators
Principal Investigator: David F Kong, MD Duke University
Study Chair: Mitchell W Krucoff, MD Duke University
  More Information

Responsible Party: David Kong, M.D., Study Principal Investigator, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT02939976     History of Changes
Other Study ID Numbers: Pro00076262
First Submitted: October 18, 2016
First Posted: October 20, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by David Kong, M.D., Duke University Medical Center:
ST-Elevation Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs