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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Combined Intervention

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

Group Type ACTIVE_COMPARATOR

Combined Intervention

Intervention Type PROCEDURE

pre-PCI intracoronary vasodilator administration and glycoprotein IIb/IIIa inhibitor administration, use of an embolization protection device if technically feasible, and complete coverage of the lipid core plaque, if technically feasible

Conventional PCI

Group Type ACTIVE_COMPARATOR

Conventional PCI

Intervention Type PROCEDURE

Conventional PCI

Interventions

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Combined Intervention

pre-PCI intracoronary vasodilator administration and glycoprotein IIb/IIIa inhibitor administration, use of an embolization protection device if technically feasible, and complete coverage of the lipid core plaque, if technically feasible

Intervention Type PROCEDURE

Conventional PCI

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No