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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT06089135
Eligibility Criteria:
Inclusion Criteria:
* 1\. Subject is \> 21 years old 2. Subject with an indication for PCI for the treatment of a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidence of down-trending biomarkers 3. Subject is willing and able to provide informed written consent Angiographic Inclusion Criteria
1. The target lesion is a de novo native coronary lesion
2. The target vessel is a native coronary artery with either:
1. A stenosis \> 70%; or,
2. A stenosis \> 50% and \<70% with evidence of ischemia via either positive stress test, FFR value \< 0.80 or RFR/iFR/DFR value \< 0.89
3. The reference diameter of the target vessel is \> 2.5mm and \< 4.0 mm at the lesion site
4. The target lesion has evidence of significant calcium at the lesion site defined either as,
1. The presence of radiopacities involving both sides of the arterial wall \> 5mm and involving the target lesion on angiography
2. the presence of \> 270o arc of superficial calcium on intravascular imaging with a length \> 5mm or the presence of 360o arc of superficial calcium
Exclusion Criteria:
<!-- -->
1. Patient is pregnant
2. Patient is actively participating in another clinical trial
3. Known LVEF \< 25%
4. Ongoing Non-STEMI with rising biomarkers
5. Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
6. Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
7. Patient has a known allergy to contrast which cannot be adequately pre-treated
8. Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
9. Patient presents with STEMI
10. Patient is unable to tolerate dual anti-platelet therapy
11. Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days
Angiographic Exclusion Criteria
<!-- -->
1. Presence of large thrombus in the target vessel
2. Inability to pass coronary guidewire across the lesion
3. The target vessel has excessive tortuosity (Defined as presence of 2+ bends \> 90o or 3+ bends \> 75o) or other anatomic considerations that precludes intravascular imaging
4. The target lesion is within a coronary artery bypass graft
5. The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
6. Coronary artery disease that requires surgical revascularization
7. Angiographic or imaging evidence of dissection in the target vessel prior to randomization
8. Investigator feels there is not equipoise regarding the treatment strategy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06089135
Study Brief:
Protocol Section:
NCT06089135