Trial Outcomes & Findings for Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors) (NCT NCT02939976)
NCT ID: NCT02939976
Last Updated: 2025-04-29
Results Overview
Defined as cardiac death, infarct artery target-vessel MI, or ischemia-driven index infarct related vessel revascularization (IIVR) by percutaneous or surgical methods.
TERMINATED
NA
427 participants
1 year
2025-04-29
Participant Flow
Four participants with single vessel disease (SVD) were erroneously randomized and included in the intent-to-treat (ITT) population analyses.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
Multi-vessel CAD, Non-randomized
Participants who had contraindications to performing the randomized procedure.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
177
|
82
|
77
|
91
|
|
Overall Study
COMPLETED
|
162
|
78
|
72
|
82
|
|
Overall Study
NOT COMPLETED
|
15
|
4
|
5
|
9
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
Multi-vessel CAD, Non-randomized
Participants who had contraindications to performing the randomized procedure.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
2
|
4
|
|
Overall Study
Due to early study closure
|
4
|
3
|
2
|
3
|
Baseline Characteristics
Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
Baseline characteristics by cohort
| Measure |
Single Vessel Disease, Not Randomized
n=177 Participants
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.
|
Randomized to IRA Group
n=82 Participants
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.
|
Randomized to iFR Group
n=77 Participants
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.
|
Multi-vessel CAD, Non-randomized
n=91 Participants
Participants who had contraindications to performing the randomized procedure.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 7.0 • n=39 Participants
|
71.6 years
STANDARD_DEVIATION 7.4 • n=41 Participants
|
72.0 years
STANDARD_DEVIATION 7.3 • n=35 Participants
|
73.8 years
STANDARD_DEVIATION 7.7 • n=31 Participants
|
71.6 years
STANDARD_DEVIATION 7.4 • n=146 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
123 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=39 Participants
|
57 Participants
n=41 Participants
|
59 Participants
n=35 Participants
|
65 Participants
n=31 Participants
|
304 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
29 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=39 Participants
|
76 Participants
n=41 Participants
|
75 Participants
n=35 Participants
|
83 Participants
n=31 Participants
|
398 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
29 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
15 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
157 Participants
n=39 Participants
|
71 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
78 Participants
n=31 Participants
|
377 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=39 Participants
|
54 participants
n=41 Participants
|
49 participants
n=35 Participants
|
59 participants
n=31 Participants
|
256 participants
n=146 Participants
|
|
Region of Enrollment
Canada
|
83 participants
n=39 Participants
|
28 participants
n=41 Participants
|
28 participants
n=35 Participants
|
32 participants
n=31 Participants
|
171 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
Defined as cardiac death, infarct artery target-vessel MI, or ischemia-driven index infarct related vessel revascularization (IIVR) by percutaneous or surgical methods.
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE)
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
Defined as all-cause mortality, recurrent MI, heart failure (requiring hospitalization or 12 hour ER visit) or ischemia-driven revascularization for all treated arteries.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Adjudicated 1-year Modified CvLPRIT (Complete Versus Lesion-only Primary PCI Trial) MACE
|
9 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: During procedurePopulation: 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).
Primary Observational Endpoint. Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
Outcome measures
| Measure |
Medtronic Stent Population
n=427 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
TR Band
|
0 Participants
|
—
|
|
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
Without having TR Band
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 dayPopulation: Per SAP, data were stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
Primary Observational Endpoint - Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
Outcome measures
| Measure |
Medtronic Stent Population
n=427 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
TR band
|
0 Participants
|
—
|
|
Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
Without having TR Band
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Death (All Causes)
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Death (All Causes)
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Cardiac Death
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Cardiac Death
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Nonfatal (re-) MI Myocardial (Infarction)
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Nonfatal (re-) MI
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Index Infarct Related Vessel (re-) MI
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Index Infarct Related Vessel (re-) MI
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Efficacy endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Safety endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Safety endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Safety endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Safety endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Safety endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Safety endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-procedurePopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Stroke
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Stroke
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=362 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Adjudicated Stroke
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Adjudicated Death (All Causes)
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Adjudicated Death (All Causes)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Adjudicated Cardiac Death (All Causes)
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Adjudicated Cardiac Death (All Causes)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Adjudicated Stroke
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 31 to 1 yearPopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
Adjudicated Stroke
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
Secondary Observational Endpoint
Outcome measures
| Measure |
Medtronic Stent Population
n=329 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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 outcome
Timeframe: Post-procedurePopulation: Enrolled participants who experienced hemostasis are included in the analysis
Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed
Outcome measures
| Measure |
Medtronic Stent Population
n=126 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Site Reported Time to Achieve Hemostasis
Participants with Terumo TR Band
|
249.44 minutes
Standard Deviation 210.46
|
—
|
|
Site Reported Time to Achieve Hemostasis
Participants without Terumo TR Band
|
86.59 minutes
Standard Deviation 56.79
|
—
|
SECONDARY outcome
Timeframe: Post-procedurePopulation: Enrolled participants who experienced hemostasis are included in the analysis
Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed
Outcome measures
| Measure |
Medtronic Stent Population
n=126 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
Site Reported Time to Achieve Hemostasis
Participants with Terumo TR Band
|
228 minutes
Interval 94.0 to 350.0
|
—
|
|
Site Reported Time to Achieve Hemostasis
Participants without Terumo TR Band
|
96 minutes
Interval 60.0 to 138.0
|
—
|
SECONDARY outcome
Timeframe: During procedurePopulation: Enrolled participants with non-missing GlideSheath status
Outcome measures
| Measure |
Medtronic Stent Population
n=421 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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 outcome
Timeframe: During procedurePopulation: 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.
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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During index procedure in-hospitalizationSite 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During index procedureSite determination of lesion success, defined as attainment of less than 20% residual stenosis using any percutaneous method at the time of the index procedure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During index procedureSite 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During procedureOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During procedurePopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
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
|
65.91 minutes
Standard Deviation 29.90
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During procedurePopulation: 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.
Outcome measures
| Measure |
Medtronic Stent Population
n=82 Participants
Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI.
|
Randomized to iFR Group
n=77 Participants
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.
|
|---|---|---|
|
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
|
162.4 mL
Standard Deviation 72.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48-72 hours post-procedureDevice 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%
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysDevice 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%
Outcome measures
Outcome data not reported
Adverse Events
Single Vessel Disease, Not Randomized
Randomized to IRA Group
Randomized to iFR Group
Multi-vessel CAD, Non-randomized
Serious adverse events
| Measure |
Single Vessel Disease, Not Randomized
n=177 participants at risk
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.
|
Randomized to IRA Group
n=82 participants at risk
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.
|
Randomized to iFR Group
n=77 participants at risk
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.
|
Multi-vessel CAD, Non-randomized
n=91 participants at risk
Participants who had contraindications to performing the randomized procedure.
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery dissection
|
0.56%
1/177 • SAEs and AEs were assessed up to 30 days. All-cause mortality is reported up to 1 year.
|
0.00%
0/82 • SAEs and AEs were assessed up to 30 days. All-cause mortality is reported up to 1 year.
|
0.00%
0/77 • SAEs and AEs were assessed up to 30 days. All-cause mortality is reported up to 1 year.
|
0.00%
0/91 • SAEs and AEs were assessed up to 30 days. All-cause mortality is reported up to 1 year.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place