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

Coronary Artery Disease Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT05230446
• Study type: Interventional
• Source: Erasmus Medical Center
• Contact: Roberto Diletti, MD PhD
• Phone: +31 (0)10 70 352 60
• Email: r.diletti@erasmusmc.nl
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Completion date: November 18, 2027