PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions

Study Overview
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Brief Summary
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This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).

Detailed Description
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The PRESENT is an investigator-initiated, prospective, multicenter, non-randomized, single arm, OPG study. The objective performance goal is based on past results of CABG namely a rate of 7% MACCE at 1-year follow-up. All patients with multivessel disease without chronic total occlusion (CTO) and accepted for PCI are eligible for inclusion Primary endpoint The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure. Secondary endpoint Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization at 30 days, 2, and 5 years post intervention. All-cause mortality at 30 days, 1, 2, and 5 years Myocardial Infarction at 30 days, 1, 2, and 5 years Any revascularization at 30 days, 1, 2, and 5 years Stroke at 30 days, 1, 2, and 5 years Major bleeding at 30 days and 12 months Need for renal replacement therapy at 30 days

Official Title
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PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions

Conditions
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Multi Vessel Coronary Artery Disease, Non-ST Elevation Myocardial Infarction, Unstable Angina, Stable Angina, Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Coherence Tomography

Intervention / Treatment
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* Device: PCI with OCT guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years, ≤85 years The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Resolute Onyx (Zotarolimus-Eluting stent) system. The patient is willing and able to cooperate with study procedures and required follow up visits The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization Exclusion Criteria: Age <18 years and > 85 years. Single coronary vessel disease. No left anterior descending lesion. Patients in cardiogenic shock. Patients with STEMI. Presence of a chronic total occlusion (CTO) defined as coronary lesion with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial angiography present for more than or equal to 3 months. Left main coronary artery disease Patients who cannot give informed consent or have a life expectancy of less than 12 months. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors. Patients with an extreme LAD tortuosity imparing OCT catheter advancement Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint. The patient may only be enrolled once in the PRESENT study. Previous coronary artery bypass grafting (CABG). Patient requiring additional cardiac surgery within 6 months. Women of childbearing potential who do not have a negative pregnancy test result within 7 days before the procedure, women who are known to be pregnant, or who are breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Percutaneous Coronary Intervention<br>Interventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results | Device: PCI with OCT guidance<br>* Procedure will be optimize using pre-and post-stent OCT imaging, to improve the accuracy of stent placement and reduce geographic miss, but also to prevent malapposition of the stent and to discover dissections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE- 1 year | The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization | 30 days, 2, and 5 years post intervention | 
| All-cause mortality | All-cause mortality | 30 days, 1, 2, and 5 years | 
| Myocardial Infarction | Myocardial Infarction | 30 days, 1, 2, and 5 years | 
| Any revascularization | Any revascularization | 30 days, 1, 2, and 5 years | 
| Stroke | Stroke | 30 days, 1, 2, and 5 years | 
| Major bleeding | Major bleeding according to the ARC criteria | 30 days and 12 months | 
| Renal replacement therapy | Need for renal replacement therapy | 30 days |