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:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT04013906
Eligibility Criteria:
Inclusion Criteria:
* Reference vessel diameter of 2.5-4.0 mm and lesion lengths of 40 mm or less involving a de novo coronary stenosis.
* Vessel calcification must be severe angiographically as evidenced by calcium present on both sides of the vessel and extending ≥15 mm or by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) with presence of a calcium arc ≥270° in at least one cross-section.
* Calcifications should not be unable to cross with a balloon
Exclusion Criteria:
• Patients with acute coronary syndromes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04013906
Study Brief:
Protocol Section:
NCT04013906