Actively Recruiting
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Led by Erasmus Medical Center · Updated on 2022-02-09
609
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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
- Candidate for drug-eluting stent treatment following PCI guidelines and manufacturer instructions
- Target lesion characteristics meet Resolute Onyx stent system instructions for use
- Willing and able to cooperate with study procedures and follow-up visits
- Provided informed consent approved by ethics committee with data privacy authorization
You will not qualify if you...
- Age under 18 years or over 85 years
- Single coronary vessel disease
- No lesion in left anterior descending artery
- Cardiogenic shock
- ST elevation myocardial infarction
- Presence of chronic total occlusion lasting 3 months or more
- Left main coronary artery disease
- Unable to give informed consent or life expectancy less than 12 months
- Allergies or contraindications to iodinated contrast, aspirin, or P2Y12 inhibitors
- Extreme LAD tortuosity preventing OCT catheter advancement
- Enrollment in another investigational device or drug trial not completed
- Previous coronary artery bypass grafting
- Need for cardiac surgery within 6 months
- Women of childbearing potential without negative pregnancy test within 7 days, pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
H
Hala Kakar, MD
CONTACT
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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