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

Study Overview
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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.

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

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

Intervention / Treatment
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* Procedure: Combined Intervention
* Procedure: Conventional PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years. Willing and able to provide informed consent and able to comply with study procedures and follow-up. Undergoing a clinically indicated left heart coronary catheterization 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: Coexisting conditions that limit life expectancy to less than 30-days or that could affect the patient's compliance with the protocol. Positive pregnancy test or breast-feeding. High risk for bleeding. Subject is currently, or within the 30 preceding days, participating in a device or pharmaceutical treatment protocol. Clinical presentation with ST-segment elevation MI. Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg) Need for revascularization of multiple lesions during the index PCI. Unprotected left main (>50%) or equivalent left main disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combined Intervention<br>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 | Procedure: Combined Intervention<br>* 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<br>|
| Active Comparator: Conventional PCI<br>Conventional PCI | Procedure: Conventional PCI<br>* Conventional PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution |  | 18-24 hours post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB |  | 18-24 hours post-procedure | 
| Reduction in the incidence of slow flow/no-reflow post PCI |  | 2-3 hours after | 
| Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up |  | 30 days |