Actively Recruiting
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI -COMPLETE-NSTEMI-
Led by Leipzig Heart Science gGmbH · Updated on 2025-01-16
3390
Participants Needed
58
Research Sites
25 weeks
Total Duration
On this page
Sponsors
L
Leipzig Heart Science gGmbH
Lead Sponsor
H
Heart Center Leipzig at University of Leipzig
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether performing percutaneous coronary intervention PCI on all significant blockages in patients with non-ST-segment elevation myocardial infarction NSTEMI and multivessel coronary artery disease is better than treating only the main culprit lesion. This open-label, randomized, controlled, multicenter trial aims to compare these two approaches to understand which provides better outcomes for patients with this heart condition. Participants will be randomly assigned to one of two groups. One group will receive optimal medical therapy and PCI only on the culprit lesion, with no further intervention on other blockages unless certain emergency criteria occur. The other group will receive complete revascularization of all significant non-culprit lesions, either during the initial procedure, hospitalization, or within 45 days after the initial PCI. During the study, participants will be followed for an average of two years to monitor outcomes including cardiovascular death, rehospitalization for heart attacks, and other heart-related events. Researchers will also assess quality of life and complications such as bleeding, stroke, and kidney injury at various time points. The study involves regular evaluations and aims to gather comprehensive data to determine the best treatment strategy for these patients.
CONDITIONS
Brief Title
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with non-ST-segment elevation myocardial infarction (NSTEMI) as suggested by high-sensitivity troponin tests
- Have multivessel coronary artery disease
- Have an identifiable culprit lesion for treatment
- Able and willing to provide informed consent
You will not qualify if you...
- Under 18 years of age
- Currently experiencing cardiogenic shock
- Have sustained ventricular tachycardia or ventricular fibrillation
- Have contraindications for coronary revascularization
- Have had prior coronary artery bypass graft surgery
- Have indication for coronary artery bypass graft surgery
- Have non-culprit lesion located in the left main coronary artery
- Have a co-morbidity with life expectancy less than 6 months
- Diagnosed with type 2 myocardial infarction
- Are pregnant or breastfeeding
Research Team
H
Holger Thiele, MD, Prof. Dr.
H
Hans-Josef Feistritzer, MD, PhD; Assoc. Prof.
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