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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT06835660
Eligibility Criteria:
Inclusion Criteria:
* Subject age ≥ 18
* Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
* Rutherford category 2-4.
* Femoro-popliteal stenosis/occlusion
* Target lesion is below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
* Patent inflow artery (\<30% diameter stenosis).
* Patency of at least one infrapopliteal artery to the ankle (\<30% diameter stenosis) in continuity with the native femoropopliteal artery.
Exclusion Criteria:
* Inability to obtain informed consent.
* Life expectancy \<24 months.
* Pregnancy or breastfeeding during study period.
* Known clotting disorders.
* Contraindication to antiplatelet therapy or anticoagulants.
* Known hypersensitivity to nitinol or paclitaxel.
* Enrollment into another study.
* Significant iliac or common femoral stenosis (\<30% diameter) requiring intervention during the index procedure.
* In-stent restenosis
* Total occlusion non-crossable by a guidewire.
* Acute thrombosis of target vessel
* Prior ipsilateral femoro-popliteal bypass.
* Implantation of a drug-eluting stent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06835660
Study Brief:
Protocol Section:
NCT06835660