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

NCT05701358 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5100

Last updated 2025-06-19

No results posted yet for this study

Summary

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

Interventions

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.

PROCEDURE

Angiography-guided NCL PCI

PCI will be performed as per local practice

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Shamir Mehta, MD · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-22
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hungary
  • India
  • Italy
  • Norway
  • Poland
  • Serbia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701358 on ClinicalTrials.gov