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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT06535568
Eligibility Criteria:
Inclusion Criteria:
* successful PCI with solo-DCB just performed, in 1, 2 or 3 coronary vessels;
* stable or unstable coronary syndromes;
* de novo coronary lesions in vessels with diameter \>=2.0 and \<=4.0 mm (visual estimation);
* informed consent to participate in the study;
* at least one of the following criteria: \>=75 y.o.; high bleeding risk (ARC criteria)
Exclusion Criteria:
* stent implantation during index or recent (\<6 months) procedure;
* patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, contrast media, which cannot be adequately pre-medicated;
* patients participating in another clinical study; - pregnancy at the time of hospitalization;
* ST-elevation myocardial infarction;
* life expectancy \<12 months;
* left ventricular ejection fraction \<30%;
* visible thrombus at lesion site;
* target lesion/vessel with any of the following characteristics:
* severe and/or \>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory);
* left main stem stenosis \>50%;
* target lesion is in the left main stem;
* chronic total occlusion with anticipated necessity of retrograde approach;
* lesion is in a bypass graft.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT06535568
Study Brief:
Protocol Section:
NCT06535568