COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

Recruiting

• Conditions: atherosclerosis; mutivessel disease; 10011082

• Registration Number: NL-OMON51767
• Lead Sponsor: Diagram B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

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. diameter stenosis >= 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)
*Target lesions are either culprit myocardial infarction 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 multivessel disease 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cardiac death, any MI or any clinically driven revascularization at 24 months<br /><br>between FFR&OCT guided revascularization versus FFR-guided revascularization</p><br>