NCT02939976

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

Terminated NA Results posted Last updated 29 April 2025

What this trial tests

NA trial testing Single Vessel Disease in Myocardial Infarction in 427 participants. Terminated before completion.

Timeline

30 August 2017

Primary endpoint
19 July 2023

19 July 2023

Quick facts

Lead sponsor	David Kong, M.D.
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	427
Start date	30 August 2017
Primary completion	19 July 2023
Estimated completion	19 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Single Vessel Disease
• Multi-vessel Disease, Culprit Vessel Only
• Multi-vessel Disease, Complete Revascularization
• Medtronic Resolute family of stents
• Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology
• Terumo Glidesheath Slender
• Terumo TR Band Radial Compression Device

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →

Sponsor

David Kong, M.D.

Who can join

60 and older, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE) Primary · 1 year

Defined as cardiac death, infarct artery target-vessel MI, or ischemia-driven index infarct related vessel revascularization (IIVR) by percutaneous or surgical methods.

Group	Value	95% CI
Medtronic Stent Population	14

Adjudicated 1-year Modified CvLPRIT (Complete Versus Lesion-only Primary PCI Trial) MACE Primary · 1 year

Defined as all-cause mortality, recurrent MI, heart failure (requiring hospitalization or 12 hour ER visit) or ischemia-driven revascularization for all treated arteries.

Group	Value	95% CI
Randomized to IRA Group	9
Randomized to iFR Group	5

Estimate of the Incidence Rate of Radial Artery Occlusion (RAO) Primary · During procedure

Primary Observational Endpoint. Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)

TR Band

Group	Value	95% CI
Eligible Enrolled Population	0

Without having TR Band

Group	Value	95% CI
Eligible Enrolled Population	0

Estimate of the Incidence Rate of Radial Artery Occlusion (RAO) Primary · 30 day

Primary Observational Endpoint - Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)

TR band

Group	Value	95% CI
Eligible Enrolled Population	0

Without having TR Band

Group	Value	95% CI
Eligible Enrolled Population	0

Adjudicated Death (All Causes) Secondary · Baseline to 30 days

Efficacy endpoint

Group	Value	95% CI
Medtronic Stent Population	14

Adjudicated Death (All Causes) Secondary · Day 31 to 1 year

Efficacy endpoint

Group	Value	95% CI
Medtronic Stent Population	2

Adjudicated Cardiac Death Secondary · Baseline to 30 days

Efficacy endpoint

Group	Value	95% CI
Medtronic Stent Population	11

Adjudicated Cardiac Death Secondary · Day 31 to 1 year

Efficacy endpoint

Group	Value	95% CI
Medtronic Stent Population	0

Adjudicated Nonfatal (re-) MI Myocardial (Infarction) Secondary · Baseline to 30 days

Efficacy endpoint

Group	Value	95% CI
Medtronic Stent Population	4

Adjudicated Nonfatal (re-) MI Secondary · Day 31 to 1 year

Efficacy endpoint

Group	Value	95% CI
Medtronic Stent Population	4

Adjudicated Index Infarct Related Vessel (re-) MI Secondary · Baseline to 30 days

Efficacy endpoint

Group	Value	95% CI
Medtronic Stent Population	0

Adjudicated Index Infarct Related Vessel (re-) MI Secondary · Day 31 to 1 year

Efficacy endpoint

Group	Value	95% CI
Medtronic Stent Population	0

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs and AEs were assessed up to 30 days. All-cause mortality is reported up to 1 year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Vessel Disease, Not Randomized

Serious: 1/177 (1%)

Deaths: 10/177

Randomized to IRA Group

Serious: 0/82 (0%)

Deaths: 4/82

Randomized to iFR Group

Serious: 0/77 (0%)

Deaths: 3/77

Multi-vessel CAD, Non-randomized

Serious: 0/91 (0%)

Deaths: 6/91

Serious adverse events (1 terms)

Reaction	System	Single Vessel Disease, Not…	Randomized to IRA Group	Randomized to iFR Group	Multi-vessel CAD, Non-rand…
Coronary artery dissection	Cardiac disorders	—	—	—	—

Most-reported serious reactions: Coronary artery dissection.

Data from ClinicalTrials.gov NCT02939976 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Timing of Complete Revascularization in Patients with STEMI and Multivessel Disease: A Systematic Review and Meta-Analysis.
   Panuccio G, Salerno N, De Rosa S, Torella D. · · 2023 · cited 12× · PMID 39077406 · DOI 10.31083/j.rcm2402058
2. Comparative Outcomes of Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction Among Medicare Beneficiaries With Multivessel Coronary Artery Disease: An National Cardiovascular Data Registry Research to Practice Project.
   Secemsky EA, Butala N, Raja A, Khera R, et al · · 2021 · cited 5× · PMID 34372676 · DOI 10.1161/circinterventions.120.010323
3. Management of Non-Culprit Lesions in STEMI Patients with Multivessel Disease.
   Piccolo R, Manzi L, Simonetti F, Leone A, et al · · 2023 · cited 3× · PMID 37048655 · DOI 10.3390/jcm12072572
4. Complete Revascularisation Following Acute MI: A Contemporary Review.
   Gonnah A, Darke N, Mullen L, Hung J, et al · · 2025 · PMID 40171022 · DOI 10.15420/icr.2024.39