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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT05904951
Eligibility Criteria:
Inclusion Criteria:
* To be a Turkish citizen,
* To be \>18 years of age,
* Lesion must be successfully crossed with a guidewire without complication,
* INVADER™ PTCA is used in the primary lesion treated during the procedure,
* Patient has signed and dated the informed consent.
Exclusion Criteria:
* Patients who have a known allergic reaction to any of the composition of INVADER™ PTCA Balloon Dilatation Catheter.
* Device use not consistent with Instructions for Use (IFU).
* Patients concurrently participating in another medical device or pharmaceutical clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05904951
Study Brief:
Protocol Section:
NCT05904951