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

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.

Conditions

• Myocardial Infarction

Interventions

DEVICE

Single Vessel Disease

Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device

PROCEDURE

Multi-vessel Disease, Culprit Vessel Only

Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device

PROCEDURE

Multi-vessel Disease, Complete Revascularization

Complete revascularization of all diseased arteries

DEVICE

Medtronic Resolute family of stents

Revascularization with Medtronic Resolute family of stents in infarct related artery

DEVICE

Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology

Complete revascularization of all diseased arteries

DEVICE

Terumo Glidesheath Slender

Possible use of Terumo Glidesheath Slender

DEVICE

Terumo TR Band Radial Compression Device

Possible use of Terumo TR Band Radial Compression Device

Sponsors & Collaborators

• Medtronic Vascular

  collaborator INDUSTRY

• Volcano Corporation

  collaborator INDUSTRY

• Terumo Medical Corporation

  collaborator INDUSTRY

• David Kong, M.D.

  lead OTHER

Principal Investigators

• David F Kong, MD · Duke University

• Mitchell W Krucoff, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-30

Primary Completion

2023-07-19

Completion

2023-07-19

FDA Device

Yes

Countries

• United States

Study Locations