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

David Kong, M.D.

Status: Terminated

Conditions: Myocardial Infarction

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02939976

Pro00076262

Details and patient eligibility

About

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.

Full 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

Enrollment: 427 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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427 participants in 3 patient groups

Single Vessel Disease

Active Comparator group

Description:

Standard of care comparator for those subjects with single vessel coronary artery 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

Treatment:

Device: Terumo Glidesheath Slender

Device: Terumo TR Band Radial Compression Device

Device: Single Vessel Disease

Device: Medtronic Resolute family of stents

Multi-vessel Disease, Culprit Vessel Only

Experimental group

Description:

Subjects randomized to revascularization of infarct related artery 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

Treatment:

Device: Terumo Glidesheath Slender

Device: Terumo TR Band Radial Compression Device

Procedure: Multi-vessel Disease, Culprit Vessel Only

Device: Medtronic Resolute family of stents

Multi-vessel Disease, Complete Revascularization

Experimental group

Description:

Subjects randomized to complete revascularization. Complete revascularization of all diseased arteries with Medtronic Resolute family of stents; Use of Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology to determine which arteries to stent; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device

Treatment:

Device: Terumo Glidesheath Slender

Device: Terumo TR Band Radial Compression Device

Procedure: Multi-vessel Disease, Complete Revascularization

Device: Medtronic Resolute family of stents

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