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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT06321757
Eligibility Criteria:
Inclusion Criteria:
Patients with:
* PCI with DCB on native arteries with diameters \< 3 mm.
* Indication for PCI in acute coronary syndrome or chronic coronary syndrome or silent angina with an indication for PCI.
syndrome or silent angina with an indication for PCI.
* If previous lesion preparation was required after which angiographic residual lesion should not exist with diameter stenosis \> 30% or flow-limiting coronary dissections.
* All antithrombotic therapies administered prior to the procedure are accepted. Still, they can be changed after the procedure.
* Capacity to understand and sign the written informed consent.
* If the patient has a high-bleeding risk defined by 1) PRECISE-DAPT SCORE ≥ 25 or 2) an indication for concomitant oral anticoagulation he can be included in the high- bleeding risk substudy as long as he does not meet the specific exclusion criteria.
Exclusion Criteria:
Patients with:
* Concomitant lesions on vessels \> 3 mm in diameter in the same coronary territory.
* PCI on in-stent restenoses.
* PCI on culprit lesions of acute coronary syndrome with ST segment elevation.
* Patients with an indication for PCI on additional non-culprit lesions of acute coronary syndrome with ST segment elevation may be included in the study, if only non-culprit lesions are considered for the study.
* Life expectancy \<12 months
* Pregnancy.
* Participation in clinicaltrials.
* Inability to give the written informed consent.
* Specific exclusion criteria for the high-bleeding risk patient subgroup:
* Past medical history of stent thrombosis.
* Indication for dual antiplatelet therapy for a different reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06321757
Study Brief:
Protocol Section:
NCT06321757