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:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT05444660
Eligibility Criteria:
Inclusion Criteria:
1. Patient is \>18 years old.
2. Target Lesion is located in the infrapopliteal arteries.
3. Patient who underwent treatment (PTA) in the infrapopliteal vessels with at least one of the SABER OTW PTA Catheter the SABERX PTA Catheter and/or the Powerflex Pro PTA Catheter as described in the IFU for each device.
Exclusion Criteria:
1. Anatomy or size of vessels that would have not allowed appropriate usage of the study devices, following IFU of the study devices.
2. Patients who were not suitable for receiving interventional surgeries of lower limb arteries for treatment.
3. Women who were pregnant or lactating at time of the procedure.
4. Any patient who was considered to be hemodynamically unstable at onset of procedure.
5. Patient was not available for follow up at the clinical site.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05444660
Study Brief:
Protocol Section:
NCT05444660