Status:
ACTIVE_NOT_RECRUITING
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Lead Sponsor:
Diagram B.V.
Collaborating Sponsors:
Abbott
Conditions:
Multivessel Coronary Artery Disease
Ischemia
Eligibility:
All Genders
30-80 years
Phase:
NA
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 pat...
Detailed Description
The published COMBINE trial shows that patients carrying an OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology...
Eligibility Criteria
Inclusion
- 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):
- 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
- 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
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1222 Patients enrolled
Trial Details
Trial ID
NCT05333068
Start Date
March 16 2022
End Date
December 31 2026
Last Update
February 4 2025
Active Locations (49)
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1
Monash Medical
Clayton, Australia
2
McGill University Health Centre
Montreal, Canada
3
Hamilton Health Sciences
Ontario, Canada
4
Niagara Health System - St. Catherines Site
Ontario, Canada