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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT05650450
Eligibility Criteria:
Inclusion Criteria:
* Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (\>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD\>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment);
* Signed Patient Informed Consent/Data Release Form
Exclusion Criteria:
* Age \<18 years;
* Cardiogenic shock;
* Pregnancy or breastfeeding;
* Target vessel reference diameter (within planned device deployment segments) \<2.0 or \>5.0 mm;
* Comorbidities with life expectancy \<12 months
* Severe calcification or/tortuosity proximally or at the DCB target segment;
* Prior PCI and stent implantation in the target vessel.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05650450
Study Brief:
Protocol Section:
NCT05650450