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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT04349657
Eligibility Criteria:
Inclusion Criteria:
* Patient is ≥18 years old
* Patient presenting a score from 2 to 4 following Rutherford classification
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Patient has a life expectancy of at least 12 months
* Prior to enrolment, the guidewire has crossed the target lesion in the endovascular arm. In the surgical arm, the endarterectomy needs to be performed with primary suture or patch implantation
* De novo stenotic or restenotic (post-PTA) lesions (\<100%) located in the common femoral artery, suitable for both endovascular therapy and endarterectomy
* Target lesion is located within the native CFA: localized between 1cm proximal to the origin of the circumflex iliac artery and the proximal (2cm) superficial femoral artery and deep femoral artery (2cm) (Azéma type 2 and 3 lesions)
* There is angiographic evidence of a patent deep femoral artery and/or superficial femoral artery
* The target lesion has angiographic evidence of \>50% stenosis. Occlusions are not allowed.
Exclusion Criteria:
* Presence of another stent in the target vessel that was placed during a previous procedure
* Previous open surgery in the ipsilateral groin
* Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
* Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
* Patients with known hypersensitivity to nickel-titanium and heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
* Known allergy to contrast media that cannot be adequately pre-medicated prior to study procedure
* Patients with uncorrected bleeding disorders
* Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
* Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatment with a residual stenosis \>30%
* Use of thrombectomy, atherectomy or laser device during procedure
* Any patient considered to be hemodynamically unstable at onset of procedure
* Severe medical comorbidities (untreated coronary artery disease/congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would prelude compliance with the study protocol or 1-year life expectancy
* Major distal amputation (above the ankle) in the study limb or non-study limb
* Target lesion involves an (pseudo-)aneurysm or is adjacent to an (pseudo-)aneurysm (within 5mm)
* Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications
* Presence of an aortic, iliac or femoral artificial graft
* Occlusion in the target lesion
* Presence of an interposition graft with/without profunda reimplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04349657
Study Brief:
Protocol Section:
NCT04349657