Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (CompleteNSTEMI)

Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)

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.

Study Overview

• Status: Recruiting
• Conditions: Multivessel Coronary Artery Disease; Non-ST-elevation Myocardial Infarction
• Intervention / Treatment: Procedure: Culprit-lesion revascularization; Procedure: Non-culprit-lesion revascularization

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 patients with NSTEMI and multivessel coronary artery disease.

• Study Type: Interventional
• Enrollment (Estimated): 3390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holger Thiele, MD, Prof. Dr.; Phone Number: +49 341 865-252025; Email: holger.thiele@medizin.uni-leipzig.de
• Study Contact Backup: Name: Hans-Josef Feistritzer, MD, PhD; Assoc. Prof.; Phone Number: +49 341 865252579; Email: COMPLE-NSTEMI@leipzig-heart.de

Study Locations

• Austria
  • Graz, Austria, 8036
    • Not yet recruiting
    • LKH Univ. Klinikum Graz, Clinical Department of Cardiology
    • Contact: Gabor Thoth-Gayor, MD
  • Innsbruck, Austria, 6020
    • Not yet recruiting
    • Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III
    • Contact: Sebastian Reinstadler, MD
  • Wien, Austria, 1160
    • Not yet recruiting
    • Klinik Ottakring, 3. medizinische Abteilung
    • Contact: Alexander Geppert, MD
• Germany
  • Bad Berka, Germany, 99437
    • Recruiting
    • Zentralklinik Bad Berka, Klinik für Kardiologie
    • Contact: Philipp Lauten, MD
  • Bad Krozingen, Germany, 79189
    • Not yet recruiting
    • Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie
    • Contact: Miroslaw Ferenc, MD
  • Bad Nauheim, Germany, 61231
    • Recruiting
    • Kerckhoff Klinik
    • Contact: Maren Weferling, MD
  • Bad Oeynhausen, Germany, 32545
    • Recruiting
    • Herz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
    • Contact: Regine Brinkmann, MD
  • Berlin, Germany, 13353
    • Not yet recruiting
    • Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum
    • Contact: Tobias Trippel, MD
  • Berlin, Germany, 12683
    • Recruiting
    • BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie
    • Contact: Sebastian Winkler, MD
  • Bielefeld, Germany, 33604
    • Recruiting
    • Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin
    • Contact: Christoph Stellbrink, MD
  • Bochum, Germany, 44791
    • Not yet recruiting
    • Klinik für Kardiologie und Rhythmologie, St. Josef Hospital, Universitätsklinikmum der Ruhr-Universität Bochum
    • Contact: Arash Haghikia, MD
  • Bremen, Germany, 28277
    • Recruiting
    • Klinikum Links der Weser, Innere Medizin II
    • Contact: Harm Wienbergen, MD
  • Dessau, Germany, 06847
    • Not yet recruiting
    • Städtisches Klinikum Dessau; Klinik für Innere Medizin II (Kardiologie, Angiologie, Diabetologie, internistische Intensivmedizin)
    • Contact: Georg Fürnau, MD
  • Dortmund, Germany, 44137
    • Recruiting
    • St. Johannes Hospital, Klinik für Innere Medizin I
    • Contact: Helge Möllmann, MD
  • Dresden, Germany, 01307
    • Recruiting
    • Herzzentrum Dresden GmbH, Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie
    • Contact: Axel Linke, MD
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Heinrich Heine Universitätsklinikum Düsseldorf Institut für Kardiologie, Pneumologie und Angiologie
    • Contact: Christian Jung, MD
  • Erfurt, Germany, 99089
    • Recruiting
    • HELIOS Klinikum Erfurt, Medizinische Klinik III - Kardiologie
    • Contact: Alexander Lauten, MD
  • Erlangen, Germany, 91054
    • Recruiting
    • Universitätsklinikum Erlangen, Medizinische Klinik 2
    • Contact: Stephan Achenbach, MD
  • Essen, Germany, 45138
    • Recruiting
    • Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie
    • Contact: Thomas Schmitz, MD
  • Essen, Germany, 45147
    • Recruiting
    • Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie
    • Contact: Tienush Rassaf, MD
  • Freiburg, Germany, 79106
    • Not yet recruiting
    • Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie
    • Contact: Christoph Oliver, MD
  • Fulda, Germany, 36043
    • Recruiting
    • Klinikum Fulda, Medizinischen Klinik 1 - Kardiologie, Angiologie und Intensivmedizin
    • Contact: Volker Schächinger, MD
  • Gießen, Germany, 35392
    • Recruiting
    • Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik I, Kardiologie
    • Contact: Samuel Sossalla, MD
  • Greifswald, Germany, 17475
    • Not yet recruiting
    • Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B
    • Contact: Marcus Dörr, MD
  • Göttingen, Germany, 37075
    • Not yet recruiting
    • University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University
    • Contact: Karl Toischer, MD, Prof.
  • Halle Saale, Germany, 06120
    • Recruiting
    • Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III
    • Contact: Daniel Sedding, MD
  • Hamburg, Germany, 22763
    • Recruiting
    • Asklepios Klinik Altona
    • Contact: Felix Meincke, MD
  • Hamburg, Germany, 20099
    • Recruiting
    • Asklepios Klinik St. Georg, Kardiologie und Internistische Intensivmedizin
    • Contact: Eike Tigges, MD
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Klinik für Kardiologie
    • Contact: Peter Clemmensen, MD
  • Heidelberg, Germany, 69120
    • Recruiting
    • Klinik für Kardiologie, Angiologie und Pneumologie, Medizinische Klinik 3, Universitätsklinikum Heidelberg
    • Contact: Haitham Abu Sharar, MD
  • Homburg, Germany, 66421
    • Not yet recruiting
    • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II
    • Contact: Saarraangan Kulenthiran, MD
  • Jena, Germany, 07747
    • Recruiting
    • Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie, Angiologie, Internistische Intensivmedizin
    • Contact: Christian Schulze, MD
  • Karlsruhe, Germany, 76137
    • Recruiting
    • Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik III, Kardiologie, Intensivmedizin, Angiologie
    • Contact: Claudius Jacobshagen, MD
  • Kiel, Germany, 24105
    • Not yet recruiting
    • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie und internistische Intensivmedizin
    • Contact: Derk Frank, MD
  • Langen, Germany, 63225
    • Recruiting
    • Asklepios Klinik Langen, Abteilung Medizinische Klinik I
    • Contact: Ralf Lehmann, MD
  • Leipzig, Germany, 04289
    • Recruiting
    • Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
    • Contact: Holger Thiele, MD, Prof. Dr.; Email: holger.thiele@medizin.uni-leipzig.de
    • Sub-Investigator: Hans-Josef Feistritzer, MD; PhD; Assoc. Prof
    • Sub-Investigator: Alexander Jobs, MD; PhD; Assoc. Prof
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie
    • Contact: Christian Spies, MD
  • Leipzig, Germany, 04229
    • Not yet recruiting
    • Klinikum St. Georg gGmbH Klinik für Kardiologie und Internistische Intensivmedizin
    • Contact: Norbert Klein, MD
  • Ludwigshafen, Germany, 67063
    • Recruiting
    • Klinikum der Stadt Ludwigshafen, Medizinische B Klinik
    • Contact: Ralf Zahn, MD
  • Lübeck, Germany, 23538
    • Not yet recruiting
    • Universitätsklinikum Schleswig Holstein, Medizinische Klinik II, Campus Lübeck
    • Contact: Ingo Eitel, MD
  • Magdeburg, Germany, 39120
    • Not yet recruiting
    • Universitätsklinikum Magdeburg, Klinik für Kardiologie und Angiologie
    • Contact: Alexander Schmeisser, MD
  • Mannheim, Germany, 68165
    • Not yet recruiting
    • Brüderklinikum Julia Lanz, Theresienkrankenhaus
    • Contact: Ramon Tschierschke, MD
  • Mannheim, Germany, 68167
    • Recruiting
    • Universitätsmedizin Mannheim, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie und Internistische Intensivmedizin
    • Contact: Ibrahim Akin, MD
  • Marburg, Germany, 35043
    • Not yet recruiting
    • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg, Klinik für Innere Medizin - Kardiologie, Angiologie und Intensivmedizin
    • Contact: Georgios Chatzis, MD
  • München, Germany, 80336
    • Recruiting
    • Klinikum der Universität München, Medizinische Klinik und Poliklinik I
    • Contact: Konstaninos Rizas, MD
  • München, Germany, 80636
    • Recruiting
    • Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
    • Contact: Adnan Kastrati, MD
  • Neumarkt, Germany, 92318
    • Not yet recruiting
    • Klinikum Neumarkt
    • Contact: Ulrich Reiser, MD
  • Nürnberg, Germany, 90471
    • Recruiting
    • Klinikum Nürnberg, Medizinische Klinik 8 - Schwerpunkt Kardiologie, Universitätsklinik der Paracelsus Medizinischen Privatuniversität
    • Contact: Fadil Ademaj, MD
  • Oldenburg, Germany, 26133
    • Recruiting
    • Universitätsklinik für Kardiologie am Klinikum Oldenburg
    • Contact: Albrecht Elsässer, MD
  • Plauen, Germany, 08529
    • Not yet recruiting
    • Helios Vogtland-Klinikum Plauen
    • Contact: Christian Bietau, MD
  • Regensburg, Germany, 93053
    • Recruiting
    • Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II
    • Contact: Lars Maier, MD
  • Rostock, Germany, 18057
    • Recruiting
    • Universitätsmedizin Rostock, Zentrum für Innere Medizin, Abteilung für Kardiologie
    • Contact: Alper Öner, MD
  • Schwerin, Germany, 19055
    • Recruiting
    • Helios Kliniken Schwerin, Klinik für Kardiologie und Angiologie
    • Contact: Alexander Staudt, MD
  • Trier, Germany, 54292
    • Recruiting
    • Krankenhaus der Barmherzigen Brüder Trier, Herzzentrum Innere Medizin III - Kardiologie
    • Contact: Nikos Werner, MD
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen, Medizinische Klinik, Innere Medizin III, Kardiologie und Angiologie
    • Contact: Tobias Geisler, MD
  • Villingen-Schwenningen, Germany, 78052
    • Recruiting
    • Schwarzwald-Baar Klinikum VS, Studienteam Kardiologie
    • Contact: Sebastian Ewen, MD
  • Wolfenbüttel, Germany, 38302
    • Recruiting
    • Städtisches Klinikum Wolfenbüttel gGmbH, Klinik für Innere Medizin - Kardiologie,
    • Contact: Björn Billmann, MD
  • Wuppertal, Germany, 72117
    • Recruiting
    • Helios Klinikum Wuppertal, Herzkreislaufforschung
    • Contact: Melchior Seyfarth, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: culprit-lesion-only revascularization; Patients will receive optimal medical therapy without further revascularization of non-culprit lesions (neither during index hospitalization nor during follow-up). Angina pectoris will be treated medically as recommended in the chronic coronary syndrome guidelines. Revascularization of non-culprit lesions will only be permitted if at least one bailout criteria is met.	Procedure: Culprit-lesion revascularization; Percutaneous coronary intervention of culprit-lesion; Other Names: Culprit-lesion PCI
Experimental: multivessel complete revascularization; Patients will receive complete revascularization of all angiographically significant non-culprit lesions, either during the index procedure, the index hospitalization, or staged within 45 days after PCI of the culprit lesion.	Procedure: Culprit-lesion revascularization; Percutaneous coronary intervention of culprit-lesion; Other Names: Culprit-lesion PCI; Procedure: Non-culprit-lesion revascularization; Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions; Other Names: multivessel PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction	During follow-up (2 years estimated average duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Cardiovascular death		During follow-up (2 years estimated average duration)
Rate of Rehospitalization for non-fatal myocardial infarction		During follow-up (2 years estimated average duration)
Rate of all-cause death		During follow-up (2 years estimated average duration)
Rate of ischemia-driven revascularization		During follow-up (2 years estimated average duration)
Rate of rehospitalization for heart failure		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		During follow-up (2 years estimated average duration)
Rate of coronary artery bypass surgery		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	12 months
Rate of bleeding		6 months
Rate of stroke	Ischemic and Hemorrhagic	6 months
Rate of contrast-induced acute kidney injury	AKIN grade I-III	6 months
Rate of coronary procedure-related myocardial infarction		6 months

Collaborators and Investigators

• Sponsor: Leipzig Heart Science gGmbH
• Collaborators: German Federal Ministry of Education and Research; IHF GmbH - Institut für Herzinfarktforschung; Heart Center Leipzig at University of Leipzig; Stiftung IHF - Institut für Herzinfarktforschung
• Investigators: Study Chair: Holger Thiele, MD, Prof. Dr., Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: NSTEMI; Multivessel coronary artery disease; culprit-lesion only PCI; multivessel percutaneous coronary intervention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia; Non-ST Elevated Myocardial Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction
• Other Study ID Numbers: 2023-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No