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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06657833
Eligibility Criteria:
Inclusion Criteria:
Patients must meet all inclusion criteria:
* Patients \>18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and
* Severe coronary lesion with calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and;
* Lesion to treat in a vessel between 2.5 and 4 mm.
Exclusion Criteria:
Patients must not meet any criteria
* Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
* Pregnant or breastfeeding patients.
* Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.
* Impossibility to maintain double antiplatelet treatment during at least 1 month.
* Life expectancy \<1 year.
* Index lesion at left main stem.
* Aorto-ostial lesion.
* Target lesion previously treated with stents or DEB.
* High thrombus burden in the target lesion (TIMI thrombus scaleā„3).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06657833
Study Brief:
Protocol Section:
NCT06657833