Status:
RECRUITING
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI
Lead Sponsor:
Leipzig Heart Science gGmbH
Collaborating Sponsors:
Heart Center Leipzig at University of Leipzig
German Federal Ministry of Education and Research
Conditions:
Non-ST-elevation Myocardial Infarction
Multivessel Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-S...
Detailed Description
The complete revascularization versus culprit lesion only PCI in NSTEMI (COMPLETE-NSTEMI) trial aims to investigate whether multivessel complete PCI is superior over culprit-lesion only PCI in patient...
Eligibility Criteria
Inclusion Criteria:
- NSTEMI as suggested by high-sensitivity troponin algorithms
- Multivessel coronary artery disease
- Identifiable culprit lesion
- Informed consent
Exclusion Criteria:
- Age <18 years
- Cardiogenic shock
- Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF)
- Contraindication for coronary revascularization
- Prior coronary artery bypass graft
- Indication for coronary artery bypass graft surgery
- Non-culprit lesion located in the left main coronary artery
- Co-morbidity with life expectancy less than 6 months
- Type 2 myocardial infarction
- Pregnancy and breast feeding period
Key Trial Info
Start Date :
October 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
3390 Patients enrolled
Trial Details
Trial ID
NCT05786131
Start Date
October 27 2023
End Date
July 31 2027
Last Update
January 16 2025
Active Locations (58)
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1
LKH Univ. Klinikum Graz, Clinical Department of Cardiology
Graz, Austria, 8036
2
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III
Innsbruck, Austria, 6020
3
Klinik Ottakring, 3. medizinische Abteilung
Vienna, Austria, 1160
4
Zentralklinik Bad Berka, Klinik für Kardiologie
Bad Berka, Germany, 99437