Actively Recruiting
Prospective Evaluation of Complete Revascularization Using PCI with OCT Guidance in Patients 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
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- Candidates suitable for drug-eluting stent treatment following PCI guidelines and manufacturer's instructions
- Target lesion characteristics fit the device's instructions for use
- Willing and able to cooperate with study procedures and follow-up visits
- Provided informed consent including data privacy authorization
You will not qualify if you...
- Age below 18 or above 85 years
- Single coronary vessel disease
- No lesion in the left anterior descending artery
- Cardiogenic shock
- ST-elevation myocardial infarction (STEMI)
- Presence of chronic total occlusion lesion for 3 or more months
- Left main coronary artery disease
- Unable to give informed consent or life expectancy less than 12 months
- Allergies or contraindications to contrast agents or study medications
- Extreme tortuosity of the left anterior descending artery preventing OCT catheter use
- Enrolled in another investigational device or drug trial without primary endpoint reached
- Previous coronary artery bypass grafting (CABG)
- Need for additional cardiac surgery within 6 months
- Women of childbearing potential without negative pregnancy test, pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo PCI with OCT guidance to optimize stent placement and improve treatment outcomes.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored for safety and clinical outcomes including major adverse cardiac and cerebrovascular events.
Visits at 30 days, 1 year, 2 years, and 5 years post intervention
Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
R
Roberto Diletti, MD PhD
H
Hala Kakar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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