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

Myocardial Infarction Clinical Trial

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

Status Terminated

Clinical Trial Summary

Patients with partially blocked blood vessel(s) in their heart may need a medical procedure called "Percutaneous Coronary Intervention (PCI)" to open the narrowed blood vessel(s). The purpose of this study is to simultaneously address four potential advances in ST-Elevation Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are looking to see if these advances can improve the outcome for these patients.

1. Opening the arteries with a Medtronic stent

2. Radial access (from wrist) success with a Medtronic stent

3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.

4. Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.

Clinical Trial Description

Multicenter, randomized, open-label, unblinded, active and historical-controlled trial in which approximately 875 seniors undergoing urgent PCI from approximately 70 centers will be enrolled. All consented subjects will undergo attempted radial arterial access.

For DES (Drug Eluting Stent) eligible patients without randomization exclusion criteria and with multi-vessel disease identified during initial angiogram will be randomized by site in a ratio of 1:1 to IRA-only revascularization or iFR-guided complete revascularization. After randomization, subjects with stable TIMI-3 flow established in the IRA using the protocol specified treatment will proceed with the randomized procedure. Subjects in whom IRA reperfusion with TIMI-3 flow is not achieved will be treated according to clinical best practice standard of care independent of randomized procedure assignment and will not be considered protocol violations. These patients will be followed identically to all study patients.

After stent implantation, subjects will be contacted for follow-up at 30 days by the enrolling site and at 1 year by the DCRI Call Center.

Primary endpoint results will be reported after all subjects have completed 1 year (12 months) of clinical follow-up.

STEMI patients eligible for radial access:

• DES Eligible with single vessel Coronary Artery Disease (CAD) will receive DES to IRA

• DES Eligible with Multi-vessel CAD will randomize 1:1 to IRA-only revascularization or Instantaneous Wave Free Radio (iFR)-guided complete revascularization ;

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

• NCT number: NCT02939976
• Study type: Interventional
• Source: Duke University
• Status: Terminated
• Phase: N/A
• Start date: August 30, 2017
• Completion date: July 19, 2023