Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions (CONCERTO)

Veterans Affairs (VA) North Texas Health Care System

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease; Near-infrared Spectroscopy; Arteriosclerosis; Peri-procedural Myocardial Infarction

Treatments: Procedure: Conventional PCI; Procedure: Combined Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02601664

14-083

Details and patient eligibility

About

Design: Single center, single-blind randomized controlled trial of patients with high risk native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will be randomized to either a combined intervention or conventional PCI. Cardiac biomarker measurements will be performed before PCI and 18-24 hours later.

Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible.

Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution in the two study groups.

The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI. (3) Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years.
2. Willing and able to provide informed consent and able to comply with study procedures and follow-up.
3. Undergoing a clinically indicated left heart coronary catheterization
4. Need PCI of a high-risk native coronary artery lesion. High-risk lesions will be defined as lesions with ≥2 contiguous yellow blocks on block chemogram.

Exclusion criteria

1. Coexisting conditions that limit life expectancy to less than 30-days or that could affect the patient's compliance with the protocol.
2. Positive pregnancy test or breast-feeding.
3. High risk for bleeding.
4. Subject is currently, or within the 30 preceding days, participating in a device or pharmaceutical treatment protocol.
5. Clinical presentation with ST-segment elevation MI.
6. Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg)
7. Need for revascularization of multiple lesions during the index PCI.
8. Unprotected left main (>50%) or equivalent left main disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

3 participants in 2 patient groups

Combined Intervention

Active Comparator group

Description:

Combined intervention: pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible

Treatment:

Procedure: Combined Intervention

Conventional PCI

Active Comparator group

Description:

Conventional PCI

Treatment:

Procedure: Conventional PCI