Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeipzig Heart Science gGmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
NSTEMI as suggested by high-sensitivity troponin algorithms
Multivessel coronary artery disease
Identifiable culprit lesion
Informed consent
Disqualifiers
Age <18 years
Cardiogenic shock
Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF)
Contraindication for coronary revascularization
Trial design
Design model
Parallel
Treatments tested in this trial
Culprit-lesion revascularization
Procedure/SurgeryPercutaneous coronary intervention of culprit-lesion
Non-culprit-lesion revascularization
Procedure/SurgeryComplete percutaneous coronary intervention of all angiographically significant non-culprit lesions
Treatment groups
3,390 Participants
are divided into 2 treatment groupsGroup A: culprit-lesion-only revascularizationExperimental treatment 1 intervention
Group B: multivessel complete revascularizationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
Time frame
During follow-up (2 years estimated average duration)Secondary outcomes
1
Rate of Cardiovascular death
Time frame
During follow-up (2 years estimated average duration)2
Rate of Rehospitalization for non-fatal myocardial infarction
Time frame
During follow-up (2 years estimated average duration)3
Rate of all-cause death
Time frame
During follow-up (2 years estimated average duration)4
Rate of ischemia-driven revascularization
Time frame
During follow-up (2 years estimated average duration)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Leipzig Heart Science gGmbH
Lead sponsor
Heart Center Leipzig at University of Leipzig
Collaborator
German Federal Ministry of Education and Research
Collaborator
IHF GmbH - Institut für Herzinfarktforschung
Collaborator
Stiftung IHF - Institut für Herzinfarktforschung
Collaborator
Source ClinicalTrials.gov