Myocardial Infarction
Conditions
Keywords
ST-Elevation Myocardial Infarction
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
Interventions
DEVICESingle 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
PROCEDUREMulti-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
PROCEDUREMulti-vessel Disease, Complete Revascularization
Complete revascularization of all diseased arteries
DEVICEMedtronic Resolute family of stents
Revascularization with Medtronic Resolute family of stents in infarct related artery
DEVICEVolcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology
Complete revascularization of all diseased arteries
DEVICETerumo Glidesheath Slender
Possible use of Terumo Glidesheath Slender
DEVICETerumo TR Band Radial Compression Device
Possible use of Terumo TR Band Radial Compression Device
Sponsors
Medtronic Vascular
Volcano Corporation
Terumo Medical Corporation
David Kong, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Estimate of the Incidence Rate of Radial Artery Occlusion (RAO) | 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) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjudicated Nonfatal (re-) MI | Day 31 to 1 year | Efficacy endpoint |
| Adjudicated Stroke | Post-procedure | — |
| Adjudicated Cardiac Death (All Causes) | Baseline to 30 days | — |
| Heart Failure (Requiring Hospitalization or 12 Hour ER Visit) | Baseline to 30 days | — |
| 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 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 |
| Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed | During procedure | — |
| Adjudicated Death (All Causes) | Baseline to 30 days | Efficacy endpoint |
| Adjudicated Cardiac Death | Baseline to 30 days | Efficacy endpoint |
| Adjudicated Nonfatal (re-) MI Myocardial (Infarction) | Baseline to 30 days | Efficacy endpoint |
| Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven) | Baseline to 30 days | Efficacy endpoint |
| Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis | Post-Procedure (0-24 hours post stent) | Safety endpoint |
| Adjudicated Index Infarct Related Vessel (re-) MI | Baseline to 30 days | Efficacy endpoint |
| Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven) | Baseline to 30 days | Efficacy endpoint |
| Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis | Post-procedure (0-24hr post stent) | Safety endpoint |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medtronic Resolute® Family of Stents - Site Determination of Device Success | During index procedure | Site determination of device success, defined as attainment of less than 20% residual stenosis of the infarct related lesion at the time of the index procedure (IILR) using only the study stent. |
| iFR Guided Revascularization - Site Reported Index Hospitalization Bleeding and Vascular Complication Defined as Bleeding or Vascular Complication Requiring Intervention | 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 | — |
| Medtronic Resolute® Family of Stents - Site Determination of Lesion Success | During index procedure | Site determination of lesion success, defined as attainment of less than 20% residual stenosis using any percutaneous method at the time of the index procedure. |
| Medtronic Resolute® Family of Stents - Site Determination of Procedure Success | During index procedure in-hospitalization | Site determination of procedure success, defined as lesion success without the occurrence of in-hospital death, nonfatal MI, stroke, or emergency Endpoints for Evaluating iFR Guided iFR-Guided Complete Revascularization in STEMI. |
| iFR Guided Revascularization With Volcano Based Pressure Wires Verrata®, Verrata Plus® and Any Subsequent Marketed Volcano Pressure Wire Technology - Total Contrast Used | During procedure | — |
| Occurrence of Renal Insufficiency | 48-72 hours post-procedure | Device Performance Endpoint for evaluating iFR Guided iFR-Guided Complete Revascularization in STEMI. Renal insufficiency is defined as increase from baseline creatinine of at least 0.5 mg/dL or at least 25% |
Countries
United States
Participant flow
Pre-assignment details
Four participants with single vessel disease (SVD) were erroneously randomized and included in the intent-to-treat (ITT) population analyses.
Participants by arm
| Arm | Count |
|---|---|
| Single Vessel Disease, Not Randomized Standard of care comparator for those subjects with single vessel coronary artery disease who were not randomized.
Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device. | 177 |
| Randomized to IRA Group Participants randomly assigned to receive a coronary procedure involving evaluation by iFR to implant stents into multiple arteries (primary and others that are partially blocked).
The Randomized to IRA group mainly includes participants with Multi-Vessel Disease, with the addition of two participants with single vessel disease (SVD) who were erroneously randomized to the IRA group and included in the intent-to-treat (ITT) population analyses. | 82 |
| Randomized to iFR Group Participants randomly assigned to receive a coronary procedure involving evaluation by iFR to implant stents into multiple arteries (primary and others that are partially blocked).
The Randomized to iFR group mainly includes participants with Multi-Vessel Disease, with the addition of two participants with single vessel disease (SVD) who were erroneously randomized to the iFR group and included in the intent-to-treat (ITT) population analyses. | 77 |
| Multi-vessel CAD, Non-randomized Participants who had contraindications to performing the randomized procedure. | 91 |
| Total | 427 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Due to early study closure | 4 | 3 | 2 | 3 |
| Overall Study | Lost to Follow-up | 7 | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 2 | 4 |
Baseline characteristics
| Characteristic | Single Vessel Disease, Not Randomized | Total | Multi-vessel CAD, Non-randomized | Randomized to iFR Group | Randomized to IRA Group |
|---|---|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 7 | 71.6 years STANDARD_DEVIATION 7.4 | 73.8 years STANDARD_DEVIATION 7.7 | 72.0 years STANDARD_DEVIATION 7.3 | 71.6 years STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 29 Participants | 8 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 164 Participants | 398 Participants | 83 Participants | 75 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 29 Participants | 6 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 15 Participants | 4 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 157 Participants | 377 Participants | 78 Participants | 71 Participants | 71 Participants |
| Region of Enrollment Canada | 83 participants | 171 participants | 32 participants | 28 participants | 28 participants |
| Region of Enrollment United States | 94 participants | 256 participants | 59 participants | 49 participants | 54 participants |
| Sex: Female, Male Female | 54 Participants | 123 Participants | 26 Participants | 18 Participants | 25 Participants |
| Sex: Female, Male Male | 123 Participants | 304 Participants | 65 Participants | 59 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 10 / 177 | 4 / 82 | 3 / 77 | 6 / 91 |
| other Total, other adverse events | 0 / 177 | 0 / 82 | 0 / 77 | 0 / 91 |
| serious Total, serious adverse events | 1 / 177 | 0 / 82 | 0 / 77 | 0 / 91 |
Outcome results
Primary
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.
Time frame: 1 year
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE) | 14 Participants |
Primary
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.
Time frame: 1 year
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated 1-year Modified CvLPRIT (Complete Versus Lesion-only Primary PCI Trial) MACE | 9 Participants |
| Randomized to iFR Group | Adjudicated 1-year Modified CvLPRIT (Complete Versus Lesion-only Primary PCI Trial) MACE | 5 Participants |
Primary
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)
Time frame: During procedure
Population: Per SAP, all eligible single vessel CAD (coronary artery disease) and multi-vessel subjects enrolled regardless of randomization in the study. Data were stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Medtronic Stent Population | Estimate of the Incidence Rate of Radial Artery Occlusion (RAO) | TR Band | 0 Participants |
| Medtronic Stent Population | Estimate of the Incidence Rate of Radial Artery Occlusion (RAO) | Without having TR Band | 0 Participants |
Primary
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)
Time frame: 30 day
Population: Per SAP, data were stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Medtronic Stent Population | Estimate of the Incidence Rate of Radial Artery Occlusion (RAO) | TR band | 0 Participants |
| Medtronic Stent Population | Estimate of the Incidence Rate of Radial Artery Occlusion (RAO) | Without having TR Band | 0 Participants |
Secondary
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Time frame: 30 days (>24 hours through 30 days post stent)
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis | 4 Participants |
Secondary
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Time frame: Post-Procedure (0-24 hours post stent)
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis | 4 Participants |
Secondary
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
Safety endpoint
Time frame: 1 year (>30 days post stent)
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis | 2 Participants |
Secondary
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Time frame: 1 year (>30 days post stent)
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis | 2 Participants |
Secondary
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Time frame: 30 days (>24hr to 30 days post stent)
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis | 1 Participants |
Secondary
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
Safety endpoint
Time frame: Post-procedure (0-24hr post stent)
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis | 3 Participants |
Secondary
Adjudicated Cardiac Death
Efficacy endpoint
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Cardiac Death | 0 Participants |
Secondary
Adjudicated Cardiac Death
Efficacy endpoint
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Cardiac Death | 11 Participants |
Secondary
Adjudicated Cardiac Death (All Causes)
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Cardiac Death (All Causes) | 0 Participants |
| Randomized to iFR Group | Adjudicated Cardiac Death (All Causes) | 0 Participants |
Secondary
Adjudicated Cardiac Death (All Causes)
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Cardiac Death (All Causes) | 3 Participants |
| Randomized to iFR Group | Adjudicated Cardiac Death (All Causes) | 3 Participants |
Secondary
Adjudicated Death (All Causes)
Efficacy endpoint
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Death (All Causes) | 2 Participants |
Secondary
Adjudicated Death (All Causes)
Efficacy endpoint
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Death (All Causes) | 14 Participants |
Secondary
Adjudicated Death (All Causes)
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Death (All Causes) | 4 Participants |
| Randomized to iFR Group | Adjudicated Death (All Causes) | 3 Participants |
Secondary
Adjudicated Death (All Causes)
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Death (All Causes) | 0 Participants |
| Randomized to iFR Group | Adjudicated Death (All Causes) | 0 Participants |
Secondary
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
Efficacy endpoint
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven) | 2 Participants |
Secondary
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
Efficacy endpoint
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven) | 1 Participants |
Secondary
Adjudicated Index Infarct Related Vessel (re-) MI
Efficacy endpoint
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Index Infarct Related Vessel (re-) MI | 0 Participants |
Secondary
Adjudicated Index Infarct Related Vessel (re-) MI
Efficacy endpoint
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Index Infarct Related Vessel (re-) MI | 0 Participants |
Secondary
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
Efficacy endpoint
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven) | 4 Participants |
Secondary
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
Efficacy endpoint
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven) | 3 Participants |
Secondary
Adjudicated Nonfatal (re-) MI
Efficacy endpoint
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Nonfatal (re-) MI | 4 Participants |
Secondary
Adjudicated Nonfatal (re-) MI Myocardial (Infarction)
Efficacy endpoint
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Nonfatal (re-) MI Myocardial (Infarction) | 4 Participants |
Secondary
Adjudicated Stroke
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Stroke | 0 Participants |
Secondary
Adjudicated Stroke
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Stroke | 2 Participants |
| Randomized to iFR Group | Adjudicated Stroke | 0 Participants |
Secondary
Adjudicated Stroke
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Stroke | 0 Participants |
| Randomized to iFR Group | Adjudicated Stroke | 0 Participants |
Secondary
Adjudicated Stroke
Time frame: Post-procedure
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Stroke | 2 Participants |
Secondary
Adjudicated Stroke
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who used Medtronic Drug Eluting stent during at least one CathPCI are included in this analysis. The rationale for the Metronic analysis population is that all subjects were intention-to-treat with a Resolute-family stent. So a study participant would have received the Medtronic stent for STEMI regardless of whether they were in the single-vessel, multivessel, or multivessel with FFR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Adjudicated Stroke | 0 Participants |
Secondary
Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
Time frame: Day 31 to 1 year
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Heart Failure (Requiring Hospitalization or 12 Hour ER Visit) | 0 Participants |
| Randomized to iFR Group | Heart Failure (Requiring Hospitalization or 12 Hour ER Visit) | 0 Participants |
Secondary
Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
Time frame: Baseline to 30 days
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Heart Failure (Requiring Hospitalization or 12 Hour ER Visit) | 1 Participants |
| Randomized to iFR Group | Heart Failure (Requiring Hospitalization or 12 Hour ER Visit) | 0 Participants |
Secondary
Incidence of RAO, Stratified by Whether or Not the Terumo TR Band Was Employed in Combination With GlideSheath Slender
Secondary Observational Endpoint
Time frame: 30 days
Population: Per SAP, all eligible enrolled participants who used Terumo products during at least one CathPCI. Terumo products include Terumo Glidesheath Slender and/or TR Band.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic Stent Population | Incidence of RAO, Stratified by Whether or Not the Terumo TR Band Was Employed in Combination With GlideSheath Slender | Without TR Band | 0 number of events |
| Medtronic Stent Population | Incidence of RAO, Stratified by Whether or Not the Terumo TR Band Was Employed in Combination With GlideSheath Slender | On TR Band | 0 number of events |
Secondary
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
Time frame: During procedure
Population: The outcome required several parameters from medical records to determine access success. However, these parameters were not collected before the study termination, therefore, this Outcome Measure was not collected.
Secondary
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
Population: Enrolled participants with non-missing GlideSheath status
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Medtronic Stent Population | Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed | GlideSheath = No | 9 Participants |
| Medtronic Stent Population | Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed | GlideSheath = Yes | 16 Participants |
Secondary
Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR)
Time frame: 30 days
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Stent Population | Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR) | 0 Participants |
| Randomized to iFR Group | Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR) | 0 Participants |
Secondary
Site Reported Time to Achieve Hemostasis
Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed
Time frame: Post-procedure
Population: Enrolled participants who experienced hemostasis are included in the analysis
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Medtronic Stent Population | Site Reported Time to Achieve Hemostasis | Participants with Terumo TR Band | 228 minutes |
| Medtronic Stent Population | Site Reported Time to Achieve Hemostasis | Participants without Terumo TR Band | 96 minutes |
Secondary
Site Reported Time to Achieve Hemostasis
Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed
Time frame: Post-procedure
Population: Enrolled participants who experienced hemostasis are included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Stent Population | Site Reported Time to Achieve Hemostasis | Participants with Terumo TR Band | 249.44 minutes | Standard Deviation 210.46 |
| Medtronic Stent Population | Site Reported Time to Achieve Hemostasis | Participants without Terumo TR Band | 86.59 minutes | Standard Deviation 56.79 |
Other Pre-specified
iFR Guided Revascularization - Site Reported Index Hospitalization Bleeding and Vascular Complication Defined as Bleeding or Vascular Complication Requiring Intervention
Time frame: During procedure
Other Pre-specified
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
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Stent Population | iFR Guided Revascularization With Volcano Based Pressure Wires Verrata®, Verrata Plus® and Any Subsequent Marketed Volcano Pressure Wire Technology - Total Contrast Used | 144.5 mL | Standard Deviation 83.5 |
| Randomized to iFR Group | iFR Guided Revascularization With Volcano Based Pressure Wires Verrata®, Verrata Plus® and Any Subsequent Marketed Volcano Pressure Wire Technology - Total Contrast Used | 162.4 mL | Standard Deviation 72.3 |
Other Pre-specified
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
Population: Per SAP, all eligible enrolled participants who were randomized are included. This includes 4 participants who were assigned to the Single-vessel CAD group and were subsequently randomized in error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Stent Population | iFR Guided Revascularization With Volcano Based Pressure Wires Verrata®, Verrata Plus® and Any Subsequent Marketed Volcano Pressure Wire Technology - Total Procedure Time | 54.54 minutes | Standard Deviation 24.39 |
| Randomized to iFR Group | iFR Guided Revascularization With Volcano Based Pressure Wires Verrata®, Verrata Plus® and Any Subsequent Marketed Volcano Pressure Wire Technology - Total Procedure Time | 65.91 minutes | Standard Deviation 29.9 |
Other Pre-specified
Medtronic Resolute® Family of Stents - Site Determination of Device Success
Site determination of device success, defined as attainment of less than 20% residual stenosis of the infarct related lesion at the time of the index procedure (IILR) using only the study stent.
Time frame: During index procedure
Other Pre-specified
Medtronic Resolute® Family of Stents - Site Determination of Lesion Success
Site determination of lesion success, defined as attainment of less than 20% residual stenosis using any percutaneous method at the time of the index procedure.
Time frame: During index procedure
Other Pre-specified
Medtronic Resolute® Family of Stents - Site Determination of Procedure Success
Site determination of procedure success, defined as lesion success without the occurrence of in-hospital death, nonfatal MI, stroke, or emergency Endpoints for Evaluating iFR Guided iFR-Guided Complete Revascularization in STEMI.
Time frame: During index procedure in-hospitalization
Other Pre-specified
Occurrence of Renal Insufficiency
Device Performance Endpoint for evaluating iFR Guided iFR-Guided Complete Revascularization in STEMI. Renal insufficiency is defined as increase from baseline creatinine of at least 0.5 mg/dL or at least 25%
Time frame: 30 days
Other Pre-specified
Occurrence of Renal Insufficiency
Device Performance Endpoint for evaluating iFR Guided iFR-Guided Complete Revascularization in STEMI. Renal insufficiency is defined as increase from baseline creatinine of at least 0.5 mg/dL or at least 25%
Time frame: 48-72 hours post-procedure