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
Status: Recruiting
Location: See all (112) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
• Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
‣ Amenable to successful treatment with PCI
⁃ At least 50% diameter stenosis by visual estimation
⁃ At least 2.5 mm in diameter
• Planned complete revascularization strategy for qualifying MI
Locations
United States
California
UCLA
RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Kansas
Cardiovascular Research Institute of Kansas
RECRUITING
Wichita
Maryland
The Johns Hopkins University School of Medicine
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)
RECRUITING
Coon Rapids
New Jersey
RWJ Barnabas Health
RECRUITING
Jersey City
New York
Bassett Medical Center
RECRUITING
Cooperstown
NYU Grossman School of Medicine
RECRUITING
New York
VA New York Harbor HealthCare System
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
Other Locations
Australia
Westmead Hospital
RECRUITING
Westmead
Austria
Klinik Floridsdorf
RECRUITING
Vienna
Canada
William Osler Health System
RECRUITING
Brampton
University of Alberta Hospital, Mazankowski Heart
RECRUITING
Edmonton
Hamilton Health Sciences
RECRUITING
Hamilton
Kingston Health Sciences Centre
RECRUITING
Kingston
St. Mary's General Hospital
RECRUITING
Kitchener
London Health Sciences Centre
RECRUITING
London
Centre Hospitalier de l'Universite de Montreal
RECRUITING
Montreal
Hopital du Sacre-Coeur de Montreal
RECRUITING
Montreal
McGill University Health Centre (MUHC)
RECRUITING
Montreal
Southlake Regional Health Centre
RECRUITING
Newmarket
Nova Scotia Health
RECRUITING
Nova Scotia
University of Ottawa Heart Institute
RECRUITING
Ottawa
Institut Universitaire de Cardiologie et de Pneumologie de Québec
RECRUITING
Québec
Regina General Hospital
RECRUITING
Regina
Royal University Hospital
RECRUITING
Saskatoon
Niagara Health
RECRUITING
St. Catharines
Newfoundland and Labrador Health Services
RECRUITING
St. John's
Thunder Bay Regional Health Sciences Centre
RECRUITING
Thunder Bay
St. Michael's Hospital (Unity Health Toronto)
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Ciusss McQ - Chaur
RECRUITING
Trois-rivières
St Paul's Hospital
RECRUITING
Vancouver
Vancouver General Hospital
RECRUITING
Vancouver
St. Boniface Hospital
RECRUITING
Winnipeg
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet - Copenhagen University Hospital
RECRUITING
Copenhagen
Finland
Helsinki University Hospital
RECRUITING
Helsinki
TAYS Sydankeskus Oy
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
Germany
St. Vinzenz-Hospital
RECRUITING
Cologne
Helios Amper-Klinikum
RECRUITING
Dachau
Universitatsklinikum Frankfurt
RECRUITING
Frankfurt
Marienkrankenhaus
RECRUITING
Hamburg
Schoen Klink Hamburg
RECRUITING
Hamburg
University Heart & Vascular Center Hamburg
RECRUITING
Hamburg
WKK Heide
RECRUITING
Heide
Hungary
Gottsegen National Cardiovascular Center
RECRUITING
Budapest
University of Szeged
RECRUITING
Szeged
India
Apollo Hospital
RECRUITING
Chennai
The Madras Medical Mission
RECRUITING
Chennai
Lisie Hospital
RECRUITING
Ernākulam
Medicover Hospitals
RECRUITING
Hyderabad
Apollo Rajshree Hospitals
RECRUITING
Indore
Rukmani Birla Hospital
RECRUITING
Jaipur
Meditrina Hospital
RECRUITING
Kollam
Caritas Hospital Trust
RECRUITING
Kottayam
Meenakshi Mission Hospital and Research Center
RECRUITING
Madurai
Krishna Institute of Medical Sciences
RECRUITING
Secunderabad
Italy
Azienda USL Toscana Sud Est
RECRUITING
Arezzo
UOC Cardiologia - Ospedale Maggiore
RECRUITING
Bologna
Azienda Ospedaliero - Universitaria di Ferrara
RECRUITING
Ferrara
Misericordia Hospital
RECRUITING
Grosseto
Azienda USL-IRCCS di Reggio Emilia, Reggio
RECRUITING
Reggio Emilia
Sant Andrea Hospital - Sapienza University
RECRUITING
Rome
Norway
Sorlandet Hospital Arendal
RECRUITING
Kristiansand
Oslo University Hospital Ulleval
RECRUITING
Oslo
Stavanger University Hospital
RECRUITING
Stavanger
University Hospital Tromso
RECRUITING
Tromsø
Poland
Provincial Specialized Hospital
RECRUITING
Legnica
Miedziowym Centrum Zdrowia S.A. w Lubinie
RECRUITING
Lubin
Medical University of Warsaw
RECRUITING
Warsaw
Serbia
Institute for Cardiovascular Diseases Dedinje
RECRUITING
Belgrade
University Clinical Center of Serbia
RECRUITING
Belgrade
Spain
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Virgen del Rocio
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Hospital Clinico Universitario de Valladolid
RECRUITING
Valladolid
Sweden
Karolinska University Hospital
RECRUITING
Huddinge
Lanssjukhuset RYHOV
RECRUITING
Jönköping
Karlstad Central Hospital
RECRUITING
Karlstad
Skane University Hospital
RECRUITING
Lund
Danderyd Hospital
RECRUITING
Stockholm
Umeå University Hospital
RECRUITING
Umeå
Uppsala University Hospital
RECRUITING
Uppsala
United Kingdom
East Kent Hospitals University NHS Foundation Trust
RECRUITING
Ashford
Blackpool Teaching Hospitals
RECRUITING
Blackpool
Ninewells Hospital
RECRUITING
Dundee
Harefield Hospital
RECRUITING
Harefield
Kettering General Hospital
RECRUITING
Kettering
University Hospitals of Leicester
RECRUITING
Leicester
Liverpool Heart and Chest Hospital
RECRUITING
Liverpool
Barts Health NHS Trust
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Free London NHS Foundation Trust
RECRUITING
London
Manchester University NHS Foundation Trust
RECRUITING
Manchester
The James Cook University Hospital
RECRUITING
Middlesbrough
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Royal Berkshire Foundation NHS Trust
RECRUITING
Reading
Sheffield Teaching Hospitals
RECRUITING
Sheffield
East and North Hertfordshire NHS Trust
RECRUITING
Stevenage
Royal Cornwall Hospitals NHS Trust
RECRUITING
Truro
The Royal Wolverhampton NHS Trust
RECRUITING
Wolverhampton
Worcestershire Acute Hospitals NHS Trust
RECRUITING
Worcester
Contact Information
Primary
COMPLETE-2 Project Office
complete-2@phri.ca
(905) 521-2100
Time Frame
Start Date: 2023-06-22
Estimated Completion Date: 2028-06
Participants
Target number of participants: 5100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Population Health Research Institute