Investigator Initiated, Multi center, Multi-Country Study to Assess Clogged Heart Vessels to Minimize Cardiovascular Events

Not Applicable

• Conditions: Health Condition 1: I209- Angina pectoris, unspecifiedHealth Condition 2: I251- Atherosclerotic heart disease of native coronary arteryHealth Condition 3: I222- Subsequent non-ST elevation (NSTEMI) myocardial infarctionHealth Condition 4: I229- Subsequent ST elevation (STEMI) myocardial infarction of unspecified site

• Registration Number: CTRI/2022/03/041188
• Lead Sponsor: Erasmus Academical Hospital Universit Libre de Bruxelles

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

For this Investigator initiated study below are the inclusion criteria

1. Patients undergoing PCI, aged 30-80 years with any clinical presentation

2. Angiographic criteria: = 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 (DS) = 50%

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 in patients with MI)

Exclusion Criteria

For this Investigator initiated study below are the 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 another lesion)

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%

Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)

11. Life expectancy less than 3 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified