Comparing complete revascularization to culprit lesion only PCI in NSTEMI patients
Official title: Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)
Run by Leipzig Heart Science gGmbH · NCT05786131 · Data updated 2026-11-12
This study tests if treating all blocked arteries instead of just the main problem artery helps people with NSTEMI feel better and recover faster.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3390 (estimated) |
| Sponsor | Leipzig Heart Science gGmbH Academic / other |
| Locations | 58 sites (Graz and 57 other locations) |
| Status | Recruiting |
| Started | October 27, 2023 |
| Main results expected | January 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | January 16, 2025 |
| Trial ID | NCT05786131 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with NSTEMI and multivessel coronary artery disease who have an identifiable culprit lesion.
✕Probably not a fit
Patients who may not benefit include those with severe comorbidities, prior coronary artery bypass grafts, or contraindications for coronary revascularization.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates whether performing multivessel percutaneous coronary intervention (PCI) is more effective than treating only the identified culprit lesion in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease. It is a prospective, randomized, controlled, multicenter, open-label trial that aims to provide insights into the benefits of complete revascularization. Participants will be randomly assigned to receive either complete revascularization or culprit-lesion only PCI. The study will assess outcomes related to heart health and recovery.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for NSTEMI patients, potentially enhancing recovery and reducing future cardiac events.
How similar studies have gone: Other studies have explored similar approaches, but this trial aims to provide more definitive evidence regarding the superiority of complete revascularization in this specific patient population.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Zentralklinik Bad Berka, Klinik für Kardiologie
Bad Berka, Germany Recruiting -
Kerckhoff Klinik
Bad Nauheim, Germany Recruiting -
Herz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
Bad Oeynhausen, Germany Recruiting -
BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie
Berlin, Germany Recruiting -
Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin
Bielefeld, Germany Recruiting -
Klinikum Links der Weser, Innere Medizin II
Bremen, Germany Recruiting
Show 44 more locations
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St. Johannes Hospital, Klinik für Innere Medizin I
Dortmund, Germany Recruiting -
Herzzentrum Dresden GmbH, Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie
Dresden, Germany Recruiting -
Heinrich Heine Universitätsklinikum Düsseldorf Institut für Kardiologie, Pneumologie und Angiologie
Düsseldorf, Germany Recruiting -
HELIOS Klinikum Erfurt, Medizinische Klinik III - Kardiologie
Erfurt, Germany Recruiting -
Universitätsklinikum Erlangen, Medizinische Klinik 2
Erlangen, Germany Recruiting -
Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie
Essen, Germany Recruiting -
Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie
Essen, Germany Recruiting -
Klinikum Fulda, Medizinischen Klinik 1 - Kardiologie, Angiologie und Intensivmedizin
Fulda, Germany Recruiting -
Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik I, Kardiologie
Giessen, Germany Recruiting -
Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III
Halle, Germany Recruiting -
Asklepios Klinik St. Georg, Kardiologie und Internistische Intensivmedizin
Hamburg, Germany Recruiting -
Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Klinik für Kardiologie
Hamburg, Germany Recruiting -
Asklepios Klinik Altona
Hamburg, Germany Recruiting -
Klinik für Kardiologie, Angiologie und Pneumologie, Medizinische Klinik 3, Universitätsklinikum Heidelberg
Heidelberg, Germany Recruiting -
Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie, Angiologie, Internistische Intensivmedizin
Jena, Germany Recruiting -
Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik III, Kardiologie, Intensivmedizin, Angiologie
Karlsruhe, Germany Recruiting -
Asklepios Klinik Langen, Abteilung Medizinische Klinik I
Langen, Germany Recruiting -
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie
Leipzig, Germany Recruiting -
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Leipzig, Germany Recruiting -
Klinikum der Stadt Ludwigshafen, Medizinische B Klinik
Ludwigshafen, Germany Recruiting -
Universitätsmedizin Mannheim, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie und Internistische Intensivmedizin
Mannheim, Germany Recruiting -
Klinikum der Universität München, Medizinische Klinik und Poliklinik I
München, Germany Recruiting -
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
München, Germany Recruiting -
Klinikum Nürnberg, Medizinische Klinik 8 - Schwerpunkt Kardiologie, Universitätsklinik der Paracelsus Medizinischen Privatuniversität
Nuremberg, Germany Recruiting -
Universitätsklinik für Kardiologie am Klinikum Oldenburg
Oldenburg, Germany Recruiting -
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II
Regensburg, Germany Recruiting -
Universitätsmedizin Rostock, Zentrum für Innere Medizin, Abteilung für Kardiologie
Rostock, Germany Recruiting -
Helios Kliniken Schwerin, Klinik für Kardiologie und Angiologie
Schwerin, Germany Recruiting -
Krankenhaus der Barmherzigen Brüder Trier, Herzzentrum Innere Medizin III - Kardiologie
Trier, Germany Recruiting -
Universitätsklinikum Tübingen, Medizinische Klinik, Innere Medizin III, Kardiologie und Angiologie
Tübingen, Germany Recruiting -
Schwarzwald-Baar Klinikum VS, Studienteam Kardiologie
Villingen-Schwenningen, Germany Recruiting -
Städtisches Klinikum Wolfenbüttel gGmbH, Klinik für Innere Medizin - Kardiologie,
Wolfenbüttel, Germany Recruiting -
Helios Klinikum Wuppertal, Herzkreislaufforschung
Wuppertal, Germany Recruiting -
LKH Univ. Klinikum Graz, Clinical Department of Cardiology
Graz, Austria Not yet recruiting -
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III
Innsbruck, Austria Not yet recruiting -
Klinik Ottakring, 3. medizinische Abteilung
Vienna, Austria Not yet recruiting -
Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie
Bad Krozingen, Germany Not yet recruiting -
Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum
Berlin, Germany Not yet recruiting -
Klinik für Kardiologie und Rhythmologie, St. Josef Hospital, Universitätsklinikmum der Ruhr-Universität Bochum
Bochum, Germany Not yet recruiting -
Städtisches Klinikum Dessau; Klinik für Innere Medizin II (Kardiologie, Angiologie, Diabetologie, internistische Intensivmedizin)
Dessau, Germany Not yet recruiting -
Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie
Freiburg im Breisgau, Germany Not yet recruiting -
University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University
Göttingen, Germany Not yet recruiting -
Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B
Greifswald, Germany Not yet recruiting -
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II
Homburg, Germany Not yet recruiting
+8 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Holger Thiele, MD, Prof. Dr.
- Email: holger.thiele@medizin.uni-leipzig.de
- Phone: +49 341 865-252025
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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Insights from the FAST-TRACK CABG Experience in Complex Multivessel Disease
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Temporary heart support with the iVAC 2L device during high-risk coronary procedures
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Cardiac MRI to find tissue damage and predict outcomes after coronary revascularization
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.