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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT05021757
Eligibility Criteria:
Inclusion Criteria:
1. Subject is ≥18 years of age
2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
3. Left ventricular ejection fraction \>25% within 6 months
4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
5. LAD, RCA or LCX (or of their branches) with:
* Stenosis of ≥70% and \<100% or
* Stenosis ≥50% and \<99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR \<0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
6. The lesion length must not exceed 40 mm
7. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
8. Evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location
Exclusion Criteria:
1. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
2. New York Heart Association (NYHA) class III or IV heart failure
3. Renal failure with serum creatinine \>2.5 mg/dL or chronic dialysis
4. Subjects in cardiogenic shock or with clinical evidence of acute heart failure
5. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
6. Previous stent within target lesion (in-stent restenosis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05021757
Study Brief:
Protocol Section:
NCT05021757