Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05701358

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

Led by Population Health Research Institute · Updated on 2025-06-19

5100

Participants Needed

113

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

CONDITIONS

Official Title

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting with STEMI or type 1 NSTEMI within 72 hours of successful culprit-lesion PCI
  • Residual coronary artery disease with at least one additional non-infarct-related artery stenosis amenable to PCI
  • Non-culprit artery stenosis of at least 50% diameter by visual estimation
  • Non-culprit artery stenosis at least 2.5 mm in diameter
  • Planned complete revascularization strategy for qualifying myocardial infarction
Not Eligible

You will not qualify if you...

  • Planned or prior coronary artery bypass graft (CABG) surgery
  • Inability to identify culprit lesion for STEMI or NSTEMI based on angiography, ECG, or wall motion abnormalities
  • Prior PCI of a non-culprit lesion in a different vessel within 45 days before randomization
  • Planned medical treatment of all qualifying non-culprit lesions without PCI
  • Severe non-culprit lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% diameter stenosis
  • Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion
  • The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
  • MI caused by non-atherothrombotic mechanisms such as type 2 MI, spontaneous coronary artery dissection, or coronary artery embolism
  • Non-cardiovascular co-morbidities with life expectancy less than 2 years
  • Any medical, geographic, or social factors preventing study participation or 5-year follow-up

AI-Screening

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Trial Site Locations

Total: 113 locations

1

UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

2

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

3

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States, 67226

Actively Recruiting

4

The Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21205

Actively Recruiting

5

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

6

Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

7

RWJ Barnabas Health

Jersey City, New Jersey, United States, 07302

Actively Recruiting

8

Bassett Medical Center

Cooperstown, New York, United States, 13326

Actively Recruiting

9

VA New York Harbor HealthCare System

New York, New York, United States, 10010

Actively Recruiting

10

NYU Grossman School of Medicine

New York, New York, United States, 10016

Actively Recruiting

11

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

12

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

13

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22903

Actively Recruiting

14

Westmead Hospital

Westmead, New South Wales, Australia

Actively Recruiting

15

Klinik Floridsdorf

Vienna, Austria

Actively Recruiting

16

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

17

William Osler Health System

Brampton, Canada

Actively Recruiting

18

University of Alberta Hospital, Mazankowski Heart

Edmonton, Canada

Actively Recruiting

19

Hamilton Health Sciences

Hamilton, Canada

Actively Recruiting

20

Kingston Health Sciences Centre

Kingston, Canada

Actively Recruiting

21

St. Mary's General Hospital

Kitchener, Canada

Actively Recruiting

22

London Health Sciences Centre

London, Canada

Actively Recruiting

23

Centre Hospitalier de l'Universite de Montreal

Montreal, Canada

Actively Recruiting

24

Hopital du Sacre-Coeur de Montreal

Montreal, Canada

Actively Recruiting

25

Southlake Regional Health Centre

Newmarket, Canada

Actively Recruiting

26

Nova Scotia Health

Nova Scotia, Canada

Actively Recruiting

27

University of Ottawa Heart Institute

Ottawa, Canada

Actively Recruiting

28

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Canada

Actively Recruiting

29

Regina General Hospital

Regina, Canada

Actively Recruiting

30

Royal University Hospital

Saskatoon, Canada

Actively Recruiting

31

Niagara Health

St. Catharines, Canada

Actively Recruiting

32

Newfoundland and Labrador Health Services

St. John's, Canada

Actively Recruiting

33

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Canada

Actively Recruiting

34

St. Michael's Hospital (Unity Health Toronto)

Toronto, Canada

Actively Recruiting

35

Sunnybrook Health Sciences Centre

Toronto, Canada

Actively Recruiting

36

Ciusss McQ - Chaur

Trois-Rivières, Canada

Actively Recruiting

37

St Paul's Hospital

Vancouver, Canada

Actively Recruiting

38

Vancouver General Hospital

Vancouver, Canada

Actively Recruiting

39

St. Boniface Hospital

Winnipeg, Canada

Actively Recruiting

40

St. Anne's University Hospital

Brno, Czechia

Actively Recruiting

41

Aalborg University Hospital

Aalborg, Denmark

Actively Recruiting

42

Aarhus University Hospital

Aarhus, Denmark

Actively Recruiting

43

Rigshospitalet - Copenhagen University Hospital

Copenhagen, Denmark

Actively Recruiting

44

Helsinki University Hospital

Helsinki, Finland

Actively Recruiting

45

TAYS Sydankeskus Oy

Tampere, Finland

Actively Recruiting

46

Turku University Hospital

Turku, Finland

Actively Recruiting

47

St. Vinzenz-Hospital

Cologne, Germany

Actively Recruiting

48

Helios Amper-Klinikum

Dachau, Germany

Actively Recruiting

49

Universitatsklinikum Frankfurt

Frankfurt, Germany

Actively Recruiting

50

Marienkrankenhaus

Hamburg, Germany

Actively Recruiting

51

Schoen Klink Hamburg

Hamburg, Germany

Actively Recruiting

52

University Heart & Vascular Center Hamburg

Hamburg, Germany

Actively Recruiting

53

WKK Heide

Heide, Germany

Actively Recruiting

54

Gottsegen National Cardiovascular Center

Budapest, Hungary

Actively Recruiting

55

University of Szeged

Szeged, Hungary

Actively Recruiting

56

Lisie Hospital

Ernākulam, Kerala, India

Actively Recruiting

57

Meditrina Hospital

Kollam, Kerala, India

Actively Recruiting

58

Caritas Hospital Trust

Kottayam, Kerala, India

Actively Recruiting

59

Apollo Rajshree Hospitals

Indore, Madhya Pradesh, India

Actively Recruiting

60

Rukmani Birla Hospital

Jaipur, Rajasthan, India

Actively Recruiting

61

Apollo Hospital

Chennai, Tamil Nadu, India

Actively Recruiting

62

The Madras Medical Mission

Chennai, Tamil Nadu, India

Actively Recruiting

63

Meenakshi Mission Hospital and Research Center

Madurai, Tamil Nadu, India

Actively Recruiting

64

Medicover Hospitals

Hyderabad, India

Actively Recruiting

65

Krishna Institute of Medical Sciences

Secunderabad, India

Actively Recruiting

66

Azienda USL Toscana Sud Est

Arezzo, Italy

Actively Recruiting

67

UOC Cardiologia - Ospedale Maggiore

Bologna, Italy

Actively Recruiting

68

Azienda Ospedaliero - Universitaria di Ferrara

Ferrara, Italy

Actively Recruiting

69

Misericordia Hospital

Grosseto, Italy

Actively Recruiting

70

Azienda USL-IRCCS di Reggio Emilia, Reggio

Reggio Emilia, Italy

Actively Recruiting

71

Sant Andrea Hospital - Sapienza University

Rome, Italy

Actively Recruiting

72

Sorlandet Hospital Arendal

Kristiansand, Arendal, Norway

Actively Recruiting

73

Oslo University Hospital Ulleval

Oslo, Norway

Actively Recruiting

74

Stavanger University Hospital

Stavanger, Norway

Actively Recruiting

75

University Hospital Tromso

Tromsø, Norway

Actively Recruiting

76

Provincial Specialized Hospital

Legnica, Lower Silesian Voivodeship, Poland

Actively Recruiting

77

Miedziowym Centrum Zdrowia S.A. w Lubinie

Lubin, Lower Silesian Voivodeship, Poland

Actively Recruiting

78

Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Actively Recruiting

79

Institute for Cardiovascular Diseases Dedinje

Belgrade, Serbia

Actively Recruiting

80

University Clinical Center of Serbia

Belgrade, Serbia

Actively Recruiting

81

Hospital Clinico San Carlos

Madrid, Spain

Actively Recruiting

82

Hospital Ramon y Cajal

Madrid, Spain

Actively Recruiting

83

Hospital Universitario de La Princesa

Madrid, Spain

Actively Recruiting

84

Hospital Universitario La Paz

Madrid, Spain

Actively Recruiting

85

Hospital Virgen del Rocio

Seville, Spain

Actively Recruiting

86

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Actively Recruiting

87

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Actively Recruiting

88

Karolinska University Hospital

Huddinge, Sweden

Actively Recruiting

89

Lanssjukhuset RYHOV

Jönköping, Sweden

Actively Recruiting

90

Karlstad Central Hospital

Karlstad, Sweden

Actively Recruiting

91

Skane University Hospital

Lund, Sweden

Actively Recruiting

92

Danderyd Hospital

Stockholm, Sweden

Actively Recruiting

93

Umeå University Hospital

Umeå, Sweden

Actively Recruiting

94

Uppsala University Hospital

Uppsala, Sweden

Actively Recruiting

95

East Kent Hospitals University NHS Foundation Trust

Ashford, United Kingdom

Actively Recruiting

96

Blackpool Teaching Hospitals

Blackpool, United Kingdom

Actively Recruiting

97

Ninewells Hospital

Dundee, United Kingdom

Actively Recruiting

98

Harefield Hospital

Harefield, United Kingdom

Actively Recruiting

99

Kettering General Hospital

Kettering, United Kingdom

Actively Recruiting

100

University Hospitals of Leicester

Leicester, United Kingdom

Actively Recruiting

101

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Actively Recruiting

102

Barts Health NHS Trust

London, United Kingdom

Actively Recruiting

103

Imperial College Healthcare NHS Trust

London, United Kingdom

Actively Recruiting

104

Royal Free London NHS Foundation Trust

London, United Kingdom

Actively Recruiting

105

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Actively Recruiting

106

The James Cook University Hospital

Middlesbrough, United Kingdom

Actively Recruiting

107

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Actively Recruiting

108

Royal Berkshire Foundation NHS Trust

Reading, United Kingdom

Actively Recruiting

109

Sheffield Teaching Hospitals

Sheffield, United Kingdom

Actively Recruiting

110

East and North Hertfordshire NHS Trust

Stevenage, United Kingdom

Actively Recruiting

111

Royal Cornwall Hospitals NHS Trust

Truro, United Kingdom

Actively Recruiting

112

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Actively Recruiting

113

Worcestershire Acute Hospitals NHS Trust

Worcester, United Kingdom

Actively Recruiting

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Research Team

C

COMPLETE-2 Project Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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