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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07326735
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or older.
2. Patient diagnosed with obstructive coronary artery disease suitable for percutaneous coronary intervention.
3. Target lesion located in a native coronary artery with reference vessel diameter of ≥2.0 mm.
4. Successful lesion preparation prior to DCB treatment (defined by \<30% residual stenosis and TIMI flow ≥2).
5. Patient able and willing to comply with scheduled follow-up evaluations at 1, 6, and 12 months.
6. Signed informed consent obtained prior to the procedure.
Exclusion Criteria:
1. ST-elevation myocardial infarction (STEMI) within the previous 48 hours.
2. Left main disease \>50% requiring stenting or surgical intervention.
3. Presence of thrombus or severe vessel calcification that prevents adequate balloon expansion.
4. Previous stenting at the target lesion within the previous 3 months.
5. Known allergy or contraindication to sirolimus, contrast media, or dual antiplatelet therapy.
6. Pregnant or breastfeeding women.
7. Life expectan
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07326735
Study Brief:
Protocol Section:
NCT07326735