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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Population Health Research Institute
Study ID
NCT05701358
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myocardial Infarction
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Physiology-guided NCL PCI — PROCEDURE
    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.
  • Angiography-guided NCL PCI — PROCEDURE
    PCI will be performed as per local practice

Study Details

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.

Key Dates

Start date
Jun 22, 2023
Status verified
Jun 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
5,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Rushi Parikh, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Krishan Soni, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Research Institute of KansasWichitaKansas67226
Bassem Chehab, MD (PRINCIPAL_INVESTIGATOR)
The Johns Hopkins University School of MedicineBaltimoreMaryland21205
Peter Johnston, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Brett Wanamaker, MD (PRINCIPAL_INVESTIGATOR)
Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)Coon RapidsMinnesota55433
Matthew Whitebeck, MD (PRINCIPAL_INVESTIGATOR)
RWJ Barnabas HealthJersey CityNew Jersey07302
Kimberly Skelding, MD (PRINCIPAL_INVESTIGATOR)
Bassett Medical CenterCooperstownNew York13326
Dhananjai Menzies, MD (PRINCIPAL_INVESTIGATOR)
NYU Grossman School of MedicineNew YorkNew York10016
Sripal Bangalore, MD (PRINCIPAL_INVESTIGATOR)
VA New York Harbor HealthCare SystemNew YorkNew York10010
Binita Shah, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Mark Menegus, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Jacqueline Tamis-Holland, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Medical CenterCharlottesvilleVirginia22903
Michael Ragosta, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CACardiovascular Research Institute of Kansas· Wichita, KSThe Johns Hopkins University School of Medicine· Baltimore, MDUniversity of Michigan· Ann Arbor, MIMetropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)· Coon Rapids, MN

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