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COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Sponsor: Diagram B.V.
Summary
The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation.
Official title: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Key Details
Gender
All
Age Range
30 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1222
Start Date
2022-03-16
Completion Date
2026-12-31
Last Updated
2025-02-04
Healthy Volunteers
No
Interventions
PCI revascularization strategy based on combined FFR and OCT assessment
PCI revascularization strategy based on combined FFR and OCT assessment All FFR ≤ 0.75 and Vulnerable plaque will be treated. VP defined as TCFA ( cap thickness ≤ 75 micron); Ruptured plaque; or Plaque erosion with \> 70 % AS or MLA \< 2.5 mm2.
PCI revascularization strategy based FFR assessment
PCI revascularization strategy based FFR assessment (all lesions with FFR≤0.80 will be treated)
Locations (49)
Monash Medical
Clayton, Australia
McGill University Health Centre
Montreal, Canada
Hamilton Health Sciences
Ontario, Canada
Niagara Health System - St. Catherines Site
Ontario, Canada
Aarhus University Hospital
Aarhus, Denmark
North-Estonia Medical Centre
Tallinn, Estonia
Centre Hospitalier Régional Universitaire de Lille
Lille, France
Clinique Louis Pasteur
Nancy, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Apex Heart Institute
Ahmedabad, India
Apollo Hospitals
Bangalore, India
Post Graduate Institute of Medical education and Research
Chandigarh, India
Humanitas Research Hospital
Milan, Italy
Policlinico Universitario Fondazione Agostino Gemelli
Rome, Italy
National University Corporation Institute of Science Tokyo
Bunkyō City, Japan
Yokohama City University Medical Center
Yokohama, Japan
National Heart Institute
Kuala Lumpur, Malaysia
OLVG
Amsterdam, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, Netherlands
Wellington Hospital
Wellington, New Zealand
Medical University of Silesia
Katowice, Poland
Jagiellonian University; John Paul II Hospital
Krakow, Poland
University Hospital Krakow
Krakow, Poland
Miedziowe Centrum Zdrowia
Lubin, Poland
Warsaw Medical University
Warsaw, Poland
Regional Specialist Hospital
Wroclaw, Poland
C.C. Iliescu Institute of Cardiology Bucharest
Bucharest, Romania
Nicolae Stăncioiu Heart Institute
Cluj-Napoca, Romania
Clinic Hospital Targu Mures & S.C. Cardio Med SRL
Târgu Mureş, Romania
Middle Slovak Institute of Cardiovascular Disease
Banská Bystrica, Slovakia
Hospital Bellvitge Barcelona
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital de La Princesa
Madrid, Spain
Hospital Gregorio Marañón Madrid
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
University Hospital La Paz
Madrid, Spain
Marqués de Valdecilla University Hospital
Santander, Spain
Hospital La Fe Valencia
Valencia, Spain
Linköping University
Linköping, Sweden
Lund University
Lund, Sweden
Universitetssjukhuset Örebro
Örebro, Sweden
Danderyd Hospital
Stockholm, Sweden
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Cheng Hsin General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan