Myocardial InfarctionNCT02939976
Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
A study testing Single Vessel Disease, Multi-vessel Disease, Culprit Vessel Only and Multi-vessel Disease, Complete Revascularization in people with Myocardial Infarction, run by David Kong, M.D. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Single Vessel Disease, Multi-vessel Disease, Culprit Vessel Only and Multi-vessel Disease, Complete Revascularization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- Subject eligible for DES implantation.
- Angiographic multi-vessel CAD determined by local visual estimation.
Who cannot join
- 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.
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- 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.
- Shock requiring pressors or mechanical circulatory assist support (IABP, Impella, ECMO, etc.) significant chronic renal disease (eGFR < 30) and/or on dialysis.
- Other angiographic exclusions:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27715
About this study
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.
- Opening the arteries with a Medtronic stent
- Radial access (from wrist) success with a Medtronic stent
- Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
- Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.
Read the 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
- Conditions
- Myocardial Infarction
- Being tested
- Single Vessel Disease, Multi-vessel Disease, Culprit Vessel Only, Multi-vessel Disease, Complete Revascularization, Medtronic Resolute family of stents, Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology
- Keywords
- ST-Elevation Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Vessel DiseaseDevice
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 OnlyProcedure or surgery
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 RevascularizationProcedure or surgery
Complete revascularization of all diseased arteries
Medtronic Resolute family of stentsDevice
Revascularization with Medtronic Resolute family of stents in infarct related artery
Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technologyDevice
Complete revascularization of all diseased arteries
Terumo Glidesheath SlenderDevice
Possible use of Terumo Glidesheath Slender
Terumo TR Band Radial Compression DeviceDevice
Possible use of Terumo TR Band Radial Compression Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 30 day
Secondary outcomes (32)
Adjudicated Death (All Causes)
Efficacy endpoint
Measured: Baseline to 30 days
Adjudicated Death (All Causes)
Efficacy endpoint
Measured: Day 31 to 1 year
Adjudicated Cardiac Death
Efficacy endpoint
Measured: Baseline to 30 days
Adjudicated Cardiac Death
Efficacy endpoint
Measured: Day 31 to 1 year
Adjudicated Nonfatal (re-) MI Myocardial (Infarction)
Efficacy endpoint
Measured: Baseline to 30 days
Adjudicated Nonfatal (re-) MI
Efficacy endpoint
Measured: Day 31 to 1 year
Adjudicated Index Infarct Related Vessel (re-) MI
Efficacy endpoint
Measured: Baseline to 30 days
Adjudicated Index Infarct Related Vessel (re-) MI
Efficacy endpoint
Measured: Day 31 to 1 year
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
Efficacy endpoint
Measured: Baseline to 30 days
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
Efficacy endpoint
Measured: Day 31 to 1 year
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
Efficacy endpoint
Measured: Baseline to 30 days
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
Efficacy endpoint
Measured: Day 31 to 1 year
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Measured: Post-Procedure (0-24 hours post stent)
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Measured: 30 days (>24 hours through 30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Measured: 1 year (>30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Measured: Post-procedure (0-24hr post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Measured: 30 days (>24hr to 30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Measured: 1 year (>30 days post stent)
Adjudicated Stroke
Measured: Post-procedure
Adjudicated Stroke
Measured: Baseline to 30 days
Adjudicated Stroke
Measured: Day 31 to 1 year
Adjudicated Death (All Causes)
Measured: Baseline to 30 days
Adjudicated Death (All Causes)
Measured: Day 31 to 1 year
Adjudicated Cardiac Death (All Causes)
Measured: Baseline to 30 days
Adjudicated Cardiac Death (All Causes)
Measured: Day 31 to 1 year
Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
Measured: Baseline to 30 days
Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
Measured: Day 31 to 1 year
Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR)
Measured: 30 days
Incidence of RAO, Stratified by Whether or Not the Terumo TR Band Was Employed in Combination With GlideSheath Slender
Secondary Observational Endpoint
Measured: 30 days
Site Reported Time to Achieve Hemostasis
Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed
Measured: Post-procedure
Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed
Measured: 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
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start30 Aug 2017
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Why it stopped: Funding for this study has been discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Kong, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Vascular, Volcano Corporation, Terumo Medical Corporation
- Responsible party
- Sponsor-investigator, David Kong, M.D., Duke University
- Investigators
- David F Kong, MD, Principal investigator, Duke UniversityMitchell W Krucoff, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939976
- Sponsor's protocol ID
- Pro00076262
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2016
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
- ClinicalTrials.gov ID
- NCT02939976
- Acronym / sponsor ID
- Pro00076262
- Conditions
- Myocardial Infarction
- Keywords
- ST-Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding for this study has been discontinued.
- Enrolment
- 427 participants (actual)
- Lead sponsor
- David Kong, M.D.University, hospital or other
- Collaborators
- Medtronic Vascular, Volcano Corporation, Terumo Medical Corporation
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Opening the arteries with a Medtronic stent
- Radial access (from wrist) success with a Medtronic stent
- Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Vessel Disease | Active comparator | Device: Single Vessel Disease, Device: Medtronic Resolute family of stents, Device: Terumo Glidesheath Slender, Device: Terumo TR Band Radial Compression DeviceStandard 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 | Experimental | Procedure: Multi-vessel Disease, Culprit Vessel Only, Device: Medtronic Resolute family of stents, Device: Terumo Glidesheath Slender, Device: Terumo TR Band Radial Compression DeviceSubjects 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 | Experimental | 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 DeviceSubjects 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Vessel DiseaseRevascularization 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 |
| Multi-vessel Disease, Culprit Vessel OnlyRevascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device | Procedure or surgery | Multi-vessel Disease, Culprit Vessel Only |
| Multi-vessel Disease, Complete RevascularizationComplete revascularization of all diseased arteries | Procedure or surgery | Multi-vessel Disease, Complete Revascularization |
| Medtronic Resolute family of stentsRevascularization with Medtronic Resolute family of stents in infarct related artery | Device | 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 technologyComplete revascularization of all diseased arteries | Device | Multi-vessel Disease, Complete Revascularization |
| Terumo Glidesheath SlenderPossible use of Terumo Glidesheath Slender | Device | Multi-vessel Disease, Complete Revascularization, Multi-vessel Disease, Culprit Vessel Only, Single Vessel Disease |
| Terumo TR Band Radial Compression DevicePossible use of Terumo TR Band Radial Compression Device | Device | Multi-vessel Disease, Complete Revascularization, Multi-vessel Disease, Culprit Vessel Only, Single Vessel Disease |
Primary outcome
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 Modified CvLPRIT (Complete Versus Lesion-only Primary PCI Trial) 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.
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
Time frame: During procedure
Primary Observational Endpoint. Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
Time frame: 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)
32 secondary outcomes
Adjudicated Death (All Causes)
Time frame: Baseline to 30 days
Adjudicated Death (All Causes)
Time frame: Day 31 to 1 year
Adjudicated Cardiac Death
Time frame: Baseline to 30 days
Adjudicated Cardiac Death
Time frame: Day 31 to 1 year
Adjudicated Nonfatal (re-) MI Myocardial (Infarction)
Time frame: Baseline to 30 days
Adjudicated Nonfatal (re-) MI
Time frame: Day 31 to 1 year
Adjudicated Index Infarct Related Vessel (re-) MI
Time frame: Baseline to 30 days
Adjudicated Index Infarct Related Vessel (re-) MI
Time frame: Day 31 to 1 year
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
Time frame: Baseline to 30 days
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
Time frame: Day 31 to 1 year
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
Time frame: Baseline to 30 days
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
Time frame: Day 31 to 1 year
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Time frame: Post-Procedure (0-24 hours post stent)
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Time frame: 30 days (>24 hours through 30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Time frame: 1 year (>30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Time frame: Post-procedure (0-24hr post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Time frame: 30 days (>24hr to 30 days post stent)
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
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
Time frame: 30 days
Site Reported Time to Achieve Hemostasis
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
Time frame: During procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David F Kong, MD principal investigator
Duke University
Mitchell W Krucoff, MD study chair
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Vessel Disease, Multi-vessel Disease, Culprit Vessel Only and Multi-vessel Disease, Complete Revascularization in people with Myocardial Infarction, run by David Kong, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE) (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.