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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT03939468
Eligibility Criteria:
Inclusion Criteria:
* Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse CAD involving segments suitable for a hybrid approach;
* Signed Patient Informed Consent/Data Release Form
Exclusion Criteria:
1. Age \<18 years;
2. Cardiogenic shock;
3. Pregnancy or breastfeeding;
4. Infarct-artery max diameter (within planned device deployment segment) \<2.0 or \>5.0 mm;
5. Comorbidities with life expectancy \<6 months;
6. Severe calcification or/tortuosity proximally or at the DCB target segment;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03939468
Study Brief:
Protocol Section:
NCT03939468