Actively Recruiting
Evaluation of Complete Revascularization Using PCI with OCT Guidance in Patients Aged 18 to 85 with Multivessel Coronary Artery Disease Excluding Chronic Total Occlusions
Led by Erasmus Medical Center · Updated on 2022-02-09
609
Participants Needed
1
Research Sites
208 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating clinical outcomes after complete revascularization using percutaneous coronary intervention PCI with imaging guidance by optical coherence tomography OCT in patients who have multivessel coronary artery disease, including those with stable angina, silent ischemia, or non-ST segment elevation acute coronary syndrome NSTE-ACS. This prospective, multicenter, non-randomized, single-arm study aims to compare results against a performance goal derived from past coronary artery bypass grafting CABG outcomes. The study uses PCI guided by OCT imaging before and after stent placement to improve accuracy and prevent complications such as malapposition or dissections. All patients receive drug-eluting stents according to specific guidelines and manufacturer instructions. This single-arm trial does not randomize participants and focuses on patients with multivessel disease excluding chronic total occlusions. Participants will be monitored for major adverse cardiac and cerebrovascular events MACCE including death, stroke, myocardial infarction, and repeat revascularization at one year after the initial procedure. Secondary assessments include these outcomes at 30 days, 2 years, and 5 years, as well as bleeding events and need for renal replacement therapy. Follow-up visits and study procedures will assess safety and effectiveness over the long term, with participation lasting up to five years post intervention.
CONDITIONS
Brief Title
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Research Team
R
Roberto Diletti, MD PhD
H
Hala Kakar, MD
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