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-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.
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 patients with NSTEMI and multivessel coronary artery disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,390
Percutaneous coronary intervention of culprit-lesion
Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions
Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
Time frame: During follow-up (2 years estimated average duration)
Rate of Cardiovascular death
Time frame: During follow-up (2 years estimated average duration)
Rate of Rehospitalization for non-fatal myocardial infarction
Time frame: During follow-up (2 years estimated average duration)
Rate of all-cause death
Time frame: During follow-up (2 years estimated average duration)
Rate of ischemia-driven revascularization
Time frame: During follow-up (2 years estimated average duration)
Rate of rehospitalization for heart failure
Time frame: During follow-up (2 years estimated average duration)
Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization
Time frame: During follow-up (2 years estimated average duration)
Rate of coronary artery bypass surgery
Time frame: During follow-up (2 years estimated average duration)
Quality of Life (EQ-5D-5L)
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score 1-5 for each dimension, 1 means best outcome EQ VAS score between 0 and 100; higher score means better outcome
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
LKH Univ. Klinikum Graz, Clinical Department of Cardiology
Graz, Austria
NOT_YET_RECRUITINGMedizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III
Innsbruck, Austria
NOT_YET_RECRUITINGKlinik Ottakring, 3. medizinische Abteilung
Vienna, Austria
NOT_YET_RECRUITINGZentralklinik Bad Berka, Klinik für Kardiologie
Bad Berka, Germany
RECRUITINGUniversitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie
Bad Krozingen, Germany
NOT_YET_RECRUITINGKerckhoff Klinik
Bad Nauheim, Germany
RECRUITINGHerz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
Bad Oeynhausen, Germany
RECRUITINGBG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie
Berlin, Germany
RECRUITINGCharité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum
Berlin, Germany
NOT_YET_RECRUITINGKlinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin
Bielefeld, Germany
RECRUITING...and 48 more locations
Rate of bleeding
Time frame: 6 months
Rate of stroke
Ischemic and Hemorrhagic
Time frame: 6 months
Rate of contrast-induced acute kidney injury
AKIN grade I-III
Time frame: 6 months
Rate of coronary procedure-related myocardial infarction
Time frame: 6 months