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:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT06238518
Eligibility Criteria:
Inclusion Criteria:
General Inclusion Criteria:
1. Patients with acute or chronic coronary artery syndrome indicated for PCI with stenting.
2. Able to understand and provide informed consent and comply with all study procedures
Angiographic Inclusion Criteria:
1. Native and de novo coronary artery disease
2. Lesion navigable by a 0.014" guidewire.
3. Target lesion is severely calcified, meeting one of the following criteria:
* Presence of calcium ≥ 270°, lengths ≥ 5mm, and thickness ≥ 0.5mm at one cross-section as assessed by OCT
* If the OCT catheter is unable to pass through the target lesion after dilatation due to calcification or tortuosity, and the target lesion is severely calcified on both sides of the arterial wall during angiography, with the length of the calcification \>15 mm, the lesion will be recognized as a severely calcified lesion, meeting the criteria for enrollment
Exclusion Criteria:
General Exclusion Criteria:
1. Patients under 18 years of age.
2. Incapable of providing informed consent.
3. Female patients who are pregnant or nursing (a pregnancy test must be conducted within 7 days before the index procedure for women of childbearing potential, as per local practice).
4. Concurrent medical conditions with a life expectancy of less than 1 year.
5. Hemodynamic instability.
6. Known contraindications to medications such as Heparin, anticoagulation, antiplatelet drugs, or contrast.
7. Active bleeding.
8. New-onset stroke or transient ischemic attack (TIA) within 90 days prior to enrollment.
9. Severe renal dysfunction (eGFR ≤ 30 ml/min).
10. Patients scheduled to undergo cardiac intervention or cardiac surgery within 30 days of the index procedure.
11. Recent ST-segment elevation myocardial infarction (STEMI) within 7 days or recent cardiogenic shock.
12. Lesions located in surgical conduits.
Angiographic Exclusion Criteria:
1. Target vessel exhibiting C-F type dissection.
2. Thrombosis observed by angiography or OCT.
3. Presence of an aneurysm within 10 mm of the target lesion.
4. Left main ostial lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06238518
Study Brief:
Protocol Section:
NCT06238518