| 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. | 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. | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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) | 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). | Posted | | Count of Participants | | Participants | | During procedure | | | | ID | Title | Description |
|---|
| OG000 | Eligible Enrolled Population | All eligible single vessel CAD (coronary artery disease) and multi-vessel participants enrolled regardless of randomization in the study. |
| |
| 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) | Per SAP, data were stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required) | Posted | | Count of Participants | | Participants | | 30 day | | | | ID | Title | Description |
|---|
| OG000 | Eligible Enrolled Population | All eligible single vessel CAD (coronary artery disease) and multi-vessel participants enrolled regardless of randomization in the study. |
| |
| Secondary | Adjudicated Death (All Causes) | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Death (All Causes) | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Cardiac Death | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Cardiac Death | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Nonfatal (re-) MI Myocardial (Infarction) | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Nonfatal (re-) MI | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Index Infarct Related Vessel (re-) MI | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Index Infarct Related Vessel (re-) MI | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven) | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven) | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven) | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven) | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis | | 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. | Posted | | Count of Participants | | Participants | | Post-Procedure (0-24 hours post stent) | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis | | 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. | Posted | | Count of Participants | | Participants | | 30 days (>24 hours through 30 days post stent) | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis | | 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. | Posted | | Count of Participants | | Participants | | 1 year (>30 days post stent) | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis | | 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. | Posted | | Count of Participants | | Participants | | Post-procedure (0-24hr post stent) | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis | | 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. | Posted | | Count of Participants | | Participants | | 30 days (>24hr to 30 days post stent) | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis | | 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. | Posted | | Count of Participants | | Participants | | 1 year (>30 days post stent) | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Stroke | | 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. | Posted | | Count of Participants | | Participants | | Post-procedure | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Stroke | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Stroke | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | Medtronic Stent Population | Among all eligible enrolled participants, those who used Medtronic Drug Eluting stent during at least one CathPCI. |
| |
| Secondary | Adjudicated Death (All Causes) | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Adjudicated Death (All Causes) | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Adjudicated Cardiac Death (All Causes) | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Adjudicated Cardiac Death (All Causes) | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Heart Failure (Requiring Hospitalization or 12 Hour ER Visit) | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Heart Failure (Requiring Hospitalization or 12 Hour ER Visit) | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR) | | 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. | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Adjudicated Stroke | | 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. | Posted | | Count of Participants | | Participants | | Baseline to 30 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Adjudicated Stroke | | 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. | Posted | | Count of Participants | | Participants | | Day 31 to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Incidence of RAO, Stratified by Whether or Not the Terumo TR Band Was Employed in Combination With GlideSheath Slender | Secondary Observational Endpoint | 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. | Posted | | Number | | number of events | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Terumo Population | All eligible enrolled participants who used Terumo products during at least one CathPCI. Terumo products include Terumo Glidesheath Slender and/or TR Band. |
| |
| Secondary | Site Reported Time to Achieve Hemostasis | Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed | Enrolled participants who experienced hemostasis are included in the analysis | Posted | | Mean | Standard Deviation | minutes | | Post-procedure | | | | ID | Title | Description |
|---|
| OG000 | Eligible Enrolled Population | All eligible single vessel CAD (coronary artery disease) and multi-vessel participants enrolled regardless of randomization in the study. |
| | |
| Secondary | Site Reported Time to Achieve Hemostasis | Secondary Observational Endpoint - Time to hemostasis stratified by whether the Terumo TR Band was employed | Enrolled participants who experienced hemostasis are included in the analysis | Posted | | Median | Inter-Quartile Range | minutes | | Post-procedure | | | | ID | Title | Description |
|---|
| OG000 | Eligible Enrolled Population | All eligible single vessel CAD (coronary artery disease) and multi-vessel participants enrolled regardless of randomization in the study. |
| | |
| Secondary | Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed | | Enrolled participants with non-missing GlideSheath status | Posted | | Count of Participants | | Participants | | During procedure | | | | ID | Title | Description |
|---|
| OG000 | Eligible Enrolled Population | All eligible single vessel CAD (coronary artery disease) and multi-vessel participants enrolled regardless of randomization in the study. |
| | |
| 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 | 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. | Posted | | | | | | During procedure | | | | ID | Title | Description |
|---|
| OG000 | Terumo 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. |
| |
| 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. | | Not Posted | | | | | | During index procedure in-hospitalization | | Participants | | | | |
| 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. | | Not Posted | | | | | | During index procedure | | Participants | | | | |
| 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. | | Not Posted | | | | | | During index procedure | | Participants | | | | |
| Other Pre-specified | iFR Guided Revascularization - Site Reported Index Hospitalization Bleeding and Vascular Complication Defined as Bleeding or Vascular Complication Requiring Intervention | | | Not Posted | | | | | | During procedure | | Participants | | | | |
| 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 | | 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. | Posted | | Mean | Standard Deviation | minutes | | During procedure | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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 | | 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. | Posted | | Mean | Standard Deviation | mL | | During procedure | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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% | | Not Posted | | | | | | 48-72 hours post-procedure | | Participants | | | | |
| 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% | | Not Posted | | | | | | 30 days | | Participants | | | | |