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:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT03365492
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years;
2. Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction;
3. Presence of one or more coronary artery stenoses \>50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or more stents;
4. Patient receives one or more BioFreedom stents resulting in a total stent length ranging from 30mm to 45mm;
Exclusion Criteria:
1. Individual is pregnant, nursing or planning to be pregnant;
2. Patient presents with STEMI;
3. Known intolerance to aspirin, clopidogrel, heparin, zinc, stainless steel, Biolimus A9TM or contrast material;
4. Inability to provide informed consent;
5. Currently participating in another trial;
6. Treatment with any DES within the previous 6 months;
7. Patient requires a stent \<2.25mm;
8. Patient requires a stent \>4.0mm;
9. Patient receives a non-study DES stent during the index procedure;
10. Use of a drug coated balloon planned at the index procedure;
11. Systemic use of a -limus drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03365492
Study Brief:
Protocol Section:
NCT03365492