Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT01915628
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Presence of coronary artery stenosis in one or two native coronary arteries from 2.25 to 4.0 mm in diameter that can be each covered with one BioMatrix FlexTM stent
3. Up to two lesions in two separate vessels to be treated
Exclusion Criteria:
1. Inability to provide informed consent;
2. Life expectancy less than 2 years;
3. Staged procedure planned within index procedure hospitalization;
4. ST elevation myocardial infarction;
5. Angiographic evidence of thrombus;
6. EF \< 20%;
7. Coronary artery bypass graft-lesion incl SVG;
8. Chronic total occlusion of the target lesion;
9. In stent restenosis
10. Bifurcation requiring 2 or more stents;
11. Left Main lesion;
12. Renal insufficiency (serum creatinine \> 260 µmolmol/L or \> 2.95mg/dl)
13. Multi-vessel disease with more than two vessels affected;
14. Have known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9 (limus compounds), contrast material;
15. Currently participating in another study;
16. Planning to have surgery within 6 months (excluding surgery which DAPT is maintained throughout the peri-surgical period);
17. Woman of childbearing potential with a positive pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01915628
Study Brief:
Protocol Section:
NCT01915628