Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease (COMPLETE-2)

February 14, 2024 updated by: Population Health Research Institute

A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

COMPLETE-2 STUDY OBJECTIVES

  1. To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR).
  2. To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

Study Type

Interventional

Enrollment (Estimated)

5100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Calgary, Canada
        • Recruiting
        • University of Calgary - Foothills Medical Centre
        • Principal Investigator:
          • Bryan Har, MD
      • Edmonton, Canada
        • Recruiting
        • University of Alberta Hospital, Mazankowski Heart
        • Principal Investigator:
          • Robert Welsh, MD
      • Hamilton, Canada
        • Recruiting
        • Hamilton Health Sciences
        • Principal Investigator:
          • Matthew Sibbald, MD
      • Kitchener, Canada
        • Recruiting
        • St. Mary's General Hospital
        • Principal Investigator:
          • Hahn Hoe Kim, MD
      • Montréal, Canada
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal
        • Principal Investigator:
          • Samer Masour, MD
      • Montréal, Canada
        • Recruiting
        • Hôpital du Sacré-Coeur de Montreal
        • Principal Investigator:
          • Erick Schampaert, MD
      • Newmarket, Canada
        • Recruiting
        • Southlake Regional Health Centre
        • Principal Investigator:
          • Warren Cantor, MD
      • Ottawa, Canada
        • Recruiting
        • University of Ottawa Heart Institute
        • Principal Investigator:
          • Derek So, MD
      • Saskatoon, Canada
        • Recruiting
        • Royal University Hospital
        • Principal Investigator:
          • Jay Shavadia, MD
      • St. John's, Canada
        • Recruiting
        • Newfoundland and Labrador Health Services
        • Principal Investigator:
          • Allison Hall, MD
      • Toronto, Canada
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Principal Investigator:
          • Mina Madan, MD
      • Toronto, Canada
        • Recruiting
        • St. Michael's Hospital (Unity Health Toronto)
        • Principal Investigator:
          • Akshay Bagai, MD
  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg University Hospital
        • Principal Investigator:
          • Ashkan Eftekhari, MD
      • Copenhagen, Denmark
        • Recruiting
        • Rigshospitalet - Copenhagen University Hospital
        • Principal Investigator:
          • Thomas Engstrom, MD
  • Germany
      • Hamburg, Germany
        • Recruiting
        • University Heart & Vascular Center Hamburg
        • Principal Investigator:
          • Fabian Brunner, MD
  • Italy
      • Ferrara, Italy
        • Recruiting
        • Azienda Ospedaliero - Universitaria di Ferrara
        • Principal Investigator:
          • Gianluca Campo, MD
      • Reggio Emilia, Italy
        • Recruiting
        • Azienda USL-IRCCS di Reggio Emilia, Reggio
        • Principal Investigator:
          • Vincenzo Guiducci, MD
      • Rome, Italy
        • Recruiting
        • Sant Andrea Hospital - Sapienza University
        • Principal Investigator:
          • Emanuele Barbato, MD
  • Sweden
      • Huddinge, Sweden
        • Recruiting
        • Karolinska University Hospital
        • Principal Investigator:
          • Liyew Desta, MD
      • Lund, Sweden
        • Recruiting
        • Skane University Hospital
        • Principal Investigator:
          • David Erlinge, MD
      • Stockholm, Sweden
        • Recruiting
        • Danderyd Hospital
        • Principal Investigator:
          • Felix Bohm, MD
      • Umeå, Sweden
        • Recruiting
        • Umeå University Hospital
        • Principal Investigator:
          • Jonas Andersson, MD
  • United Kingdom
      • Kettering, United Kingdom
        • Recruiting
        • Kettering General Hospital
        • Principal Investigator:
          • Simon Hetherington, MD
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Teaching Hospitals
        • Principal Investigator:
          • James Richardson, MD
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Principal Investigator:
          • Rushi Parikh, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cardiovascular Research Institute of Kansas
        • Principal Investigator:
          • Bassem Chehab, MD
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • The Johns Hopkins University School of Medicine
        • Principal Investigator:
          • Peter Johnston, MD
    • New York
      • Cooperstown, New York, United States, 13326
        • Recruiting
        • Bassett Medical Center
        • Principal Investigator:
          • Dhananjai Menzies, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI

  2. Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:

    1. Amenable to successful treatment with PCI
    2. At least 50% diameter stenosis by visual estimation
    3. At least 2.5 mm in diameter
  3. Planned complete revascularization strategy for qualifying MI

Exclusion Criteria:

  1. Planned or prior coronary artery bypass graft (CABG) surgery
  2. Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
  3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
  4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
  5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis
  6. Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
  7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
  8. Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism
  9. Non-cardiovascular co-morbidity with expected life expectancy <2 years
  10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physiology-guided Non-Culprit-Lesion (NCL) PCI
Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.
Procedure: Physiology-guided NCL PCI
For RFR, PCI will be performed as per local practice for all lesions with RFR ≤0.89. For FFR, PCI will be performed as per local practice for all NCLs with FFR ≤0.80.
Other: Angiography-guided NCL PCI
Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.
Procedure: Angiography-guided NCL PCI
PCI will be performed as per local practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
Time Frame: at study completion, a minimum of 2 years
at study completion, a minimum of 2 years
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
Time Frame: at study completion, a minimum of 2 years
at study completion, a minimum of 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first occurrence of the composite of CV death or new MI.
Time Frame: at study completion, a minimum of 2 years
at study completion, a minimum of 2 years
Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.
Time Frame: at study completion, a minimum of 2 years
at study completion, a minimum of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Shamir Mehta, MD, Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPLETE-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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