Clinical Research Directory

Inclusion Criteria: * Be between 18 and 85 years of age. * Able and willing to participate and comply with the protocol, including the defined follow-up schedule, by signing an Institutional Review Board (IRB) or Ethics Committee approved informed consent form. * Active venous leg ulcer (CEAP C6). * Previously completed treatment for clinically significant reflux in the superficial and/or perforator venous system of the target limb at least 3 months prior to enrollment, if clinically indicated. * Completed at least 3 months of prescribed compression therapy after any ablation. * Palpable dorsalis pedis or posterior tibial artery (DP/PT) pulses at ipsilateral foot or ankle brachial index (ABI) ≥0.8. * Be able to ambulate unassisted or with non-motorized assistive devices. * Current VLU present ≤48 months. Exclusion Criteria: * Patient is known pregnant or breast-feeding or planning to become pregnant in the following year. * If antiplatelet and anticoagulation therapy cannot be tolerated. * Previous venous stent implantation involving the target limb, target lesion, or inferior vena cava. * Previous venovenous bypass surgery involving the target limb. * Previous endovascular recanalization of the target lesion segment. * Known metal allergy precluding stent implantation. * Known or suspected to have inadequate inflow to support stent patency in the target limb. * Active cancer diagnosis. * Known positive test for COVID-19 (Sars-CoV-2) within the last 2 weeks and actively symptomatic. * Known or suspected venous outflow obstruction caused by tumor compression/encasement with or without thrombus. * Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure. * Known renal dysfunction (defined as eGFR \<30mL/min/1.73m2) that would preclude adequate contrast usage. * Diagnosed with right heart failure/pulmonary hypertension. * Has known clinically significant abnormal platelet count outside laboratory reference ranges. * Has known clinically significant abnormal white blood cell count (WBC), fever, sepsis or positive blood culture. * Organ transplant requiring immunosuppressant therapy. * Unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 3 months. * Subjects with an active diagnosis of osteomyelitis of the ipsilateral limb. * Previous or planned surgical or catheter-based procedure on index leg within 30 days before or 30 days after the index procedure. * Active participation in another investigational drug or device study. * Subject has any condition, which, in the opinion of the investigator, precludes the subject from participation.