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Clinical Trials in India / NCT05333068
Active, not recruiting Not applicable

COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

NCT05333068 · tracked via the Priya Life Science India tracker
Sponsor
Diagram B.V.
Phase
Not applicable
Started
2022-03-16
Last updated
2026-06-03

Condition(s) studied

Multivessel Coronary Artery DiseaseIschemiaVulnerable PlaqueCoronary Artery Disease

Investigational drug(s) / intervention(s)

PCI revascularization strategy based on combined FFR and OCT assessmentPCI revascularization strategy based FFR assessment

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)

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients undergoing PCI, aged 30-80 years with any clinical presentation 2. 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): I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation) \*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. Exclusion Criteria: 1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision) 2. Lesion located in a grafted segment or in a vein graft 3. In-stent restenosis lesions 4. Left main trifurcation 5. Left main lesion stand-alone (without other lesions) 6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous) 7. Chronic total occlusion 8. Spontaneous coronary dissection 9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years 10. Patients with left ventricle (LV) function less than 30% 11. Renal insufficiency (Glomerular Filtration Rate (GFR) \< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5) 12. Life expectancy less than 3 years

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Monash Medical Clayton Australia
Hamilton Health Sciences Hamilton Canada
McGill University Health Centre Montreal Canada
Niagara Health System - St. Catherines Site Saint Catharines 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

+ 9 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05333068 on ClinicalTrials.gov ↗ ← All trials in India