COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
1 other identifier
interventional
1,222
17 countries
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2022
CompletedFirst Submitted
Initial submission to the registry
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedFebruary 4, 2025
January 1, 2025
4 years
April 11, 2022
January 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months
cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months
24 months
Secondary Outcomes (2)
Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events in all lesions with a FFR between 0.76-0.80 left untreated in the experimental arm
24 months
Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months
24 months
Study Arms (2)
MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment
EXPERIMENTALMVD \> 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment
MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)
SHAM COMPARATORMVD \> 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)
Interventions
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 (all lesions with FFR≤0.80 will be treated)
Eligibility Criteria
You may qualify if:
- Patients undergoing PCI, aged 30-80 years with any clinical presentation
- Angiographic criteria: presence of ≥ 2 de novo target lesions\* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision)
- Angiographic criteria target lesion\* (all criteria I-IV should be applicable):
- \*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion.
You may not qualify if:
- Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision)
- Lesion located in a grafted segment or in a vein graft
- In-stent restenosis lesions
- Left main trifurcation
- Left main lesion stand-alone (without other lesions)
- Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous)
- Chronic total occlusion
- Spontaneous coronary dissection
- Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years
- Patients with left ventricle (LV) function less than 30%
- Renal insufficiency (Glomerular Filtration Rate (GFR) \< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
- Life expectancy less than 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diagram B.V.lead
- Abbottcollaborator
Study Sites (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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elvin Kedhi, Prof.dr.
Professor of Medicine McGill University; Director Intervention Cardiology, McGill University Health Center, Canada; Visiting Professor, Silesian Medical University Katowice, Poland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2022
First Posted
April 18, 2022
Study Start
March 16, 2022
Primary Completion
March 16, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 4, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share