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

This is an interventional treatment trial for Myocardial Infarction focused on measuring ST-Elevation Myocardial Infarction Read More

Inclusion Criteria

1. Have the capacity to understand and sign an informed consent or have a Legally Authorized Representative that can understand and sign an informed consent prior to initial arteriotomy access.
2. Age ≥ 60 years of age at the time of signing the informed consent and/or randomization.
3. Significant ST-elevation myocardial infarction or left bundle branch block (LBBB) on ECG with chest pain < 12 hours.
4. Accessible right or left radial artery conduit for PCI.
5. Physician intent to perform trans-radial PCI.
6. Willing to be contacted at 1 year by the DCRI Call Center

Study Randomization Inclusion Criteria

To be eligible for randomization in the 'IRA only vs. Complete Revascularization' phase of this trial, subjects must meet all of the above criteria and all of the following criteria subsequent to arterial access:

1. Subject eligible for DES implantation.
2. Angiographic multi-vessel CAD determined by local visual estimation.

Exclusion Criteria

1. Patient that have known medical conditions that would prevent or interrupt the recommended post procedure DES treatment regimen.
2. Patients that have known medical conditions that would prevent catheterization through the radial artery.
3. Patients that have known medical conditions that increase patient's risk above standard when using IFR.
4. Has had a cerebrovascular accident or transient ischemic neurological attack within the past 6 months.
5. Known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol.
6. Any condition associated with a life expectancy of less than 1 year.
7. Participation in another clinical study using an investigational agent or device within the past 3 months.

Study Randomization Exclusion Criteria If a subject who has been consented into the SAFE STEMI study develops or is found to have any of the following, they will not be eligible for randomization to an iFR guided complete revascularization vs. IRA-only primary PCI and will be excluded from the study.

1. Shock requiring pressors or mechanical circulatory assist support (IABP, Impella, ECMO, etc.) significant chronic renal disease (eGFR < 30) and/or on dialysis.

2. Other angiographic exclusions:

   • Single vessel CAD
   • Unprotected left main coronary artery disease
   • One or more major coronary distributions with CTO or indeterminate IRA
3. Clinical circumstances, which, in the judgment of the operator, preclude randomization.