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 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07340294
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years old
* Acute or chronic coronary syndrome requiring PCI
* De novo coronary lesions (excluding bypass grafts and prior stented lesions) with a target vessel reference diameter of ≥ 2.5 mm and ≤ 4.0 mm
* Moderate to severe calcification, meeting one of the following criteria: • Intravascular imaging criteria: IVUS calcium score ≥ 2 points (IVUS scoring standards: a. Calcification \> 270 degrees and length \> 5 mm; b. Circumferential calcification (360 degrees); c. Calcific nodules; d. Vessel diameter \< 3.5 mm) OCT calcium score ≥ 3 points (OCT scoring standards: a. Calcification ≤ 180 degrees: 0 points; \> 180 degrees: 2 points; b. Thickness ≤ 0.5 mm: 0 points; \> 0.5 mm: 1 point; c. Length ≤ 5 mm: 0 points; \> 5 mm: 1 point) • Contrast-based classification criteria apply when intravascular imaging devices cannot pass: Coronary angiography shows clear high-density calcific shadows visible during cardiac pulsation, or clear high-density calcific shadows visible both during and without cardiac pulsation, with the length of calcific shadows on both sides of the target lesion \> 5 mm.
* Willing and able to provide written informed consent
Exclusion Criteria:
* Patients under 18 years of age
* Patients unable to provide informed consent
* Pregnant or lactating female patients (pregnancy test must be performed within 7 days before surgery for women of childbearing age)
* Thrombus detected by angiography or intravascular imaging
* Patients with an expected life expectancy of less than 1 year
* Hemodynamically unstable patients
* Patients with known contraindications to heparin, anticoagulants, antiplatelet drugs, contrast agents, or other related medications
* Patients with active bleeding
* Patients with a new-onset stroke or transient ischemic attack (TIA) within 90 days before enrollment
* Patients scheduled to undergo other cardiac interventional procedures or cardiac surgery within 30 days after PCI
* Patients with ST-segment elevation myocardial infarction (STEMI) or cardiogenic shock occurring within 7 days
* Severe renal insufficiency (eGFR ≤ 30 ml/min)
* Left main coronary artery disease
* Presence of type C-F dissection in the target vessel
* Aneurysm within 10 mm of the target lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07340294
Study Brief:
Protocol Section:
NCT07340294