Coronary Artery Disease Clinical Trial
Official title:
COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
NCT number | NCT05333068 |
Other study ID # | 9357 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 16, 2022 |
Est. completion date | December 31, 2026 |
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.
Status | Recruiting |
Enrollment | 1222 |
Est. completion date | December 31, 2026 |
Est. primary completion date | March 16, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Romania | Different countries in Europe, Asia Pacific and Canada | Bucharest |
Lead Sponsor | Collaborator |
---|---|
Diagram B.V. | Abbott |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 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 | |
Secondary | Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months | Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months | 24 months |
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