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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT03745066
Eligibility Criteria:
Inclusion Criteria:
* Patients treated with one or more BioFreedom™ DCS .Patients who agree to comply with the follow up requirements. .Patients with a life expectancy of \> 1 year at time of consent. .Patients eligible to receive dual anti platelet therapy (DAPT).
* Patients who have signed an Informed Consent
Exclusion Criteria:
* Patients unable or unwilling to give documented informed consent
* Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint .Patient has received an additional stent different from a BioFreedom™ DCS stent during the index procedure.
* Pregnant or breastfeeding women
* Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for non HBR patients
* Planned surgery within 1 month of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for HBR patients
* Patients under judicial protection, tutorship or curatorship
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03745066
Study Brief:
Protocol Section:
NCT03745066