NCT05230446

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 609 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

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

Interventions

Type	Name	Description
DEVICE	PCI with OCT guidance	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.

Timeline

• Start date: 2021-11-18
• Primary completion: 2023-11-18
• Completion: 2027-11-18
• First posted: 2022-02-09
• Last updated: 2022-02-09

Locations

1 site across 1 country: Netherlands