Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System

Inclusion Criteria

• Males or non-pregnant, non-breastfeeding females ≥18 years of age at the time of consent
• Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
• Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to treatment and must use some form of contraception (abstinence is acceptable) throughout the time of clinical trial exit
• Willing and capable of complying with all required follow-up visits
• Estimated life expectancy ≥1 year
• Subject is ambulatory (use of assistive walking device such as a cane or walker is acceptable)
• Body mass index (BMI) 2 which is not amenable to medical treatment
• Platelet count 1, 000,000 cells/mm3 and/or White blood cell (WBC) 12,500 cells/mm3
• Uncorrected hemoglobin of ≤9 g/dL
• Subject is on dialysis or has an estimated glomerular filtration rate (eGFR) <30 mL/min. In subjects with diabetes mellitus, eGFR <45 mL/min.
• History of Heparin Induced Thrombocytopenia
• Presence of known aggressive clotting disorders such as Lupus Anticoagulant Disorder, Antiphospholipid antibody syndrome, homozygous gene Factor V Leiden or Prothrombin gene abnormalities, Protein C and S deficiency or Antithrombin deficiency
• Known hypersensitivity or contraindication to antiplatelet therapy or anticoagulation, nickel, or titanium
• Contrast agent allergy that cannot be managed adequately with pre-medication
• Intended concurrent adjuvant procedure (except for venoplasty) such as creation of temporary arteriovenous fistula, femoral endovenectomy or saphenous vein ablation and/or saphenous vein stripping during the index procedure
• Subjects who have had any prior surgical or endovascular procedures to the target vessel. Note that subjects who have had successful catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 90 days prior to the index procedure may be included
• Planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in subjects at high risk for pulmonary embolism) within 30 days prior to or 30 days after the index procedure
• Planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) 30 days prior to or 30 days after the index procedure
• Previous venous stenting of the target limb, the IVC, or contralateral limb if stents extend into the IVC
• Iliofemoral venous segment unsuitable for treatment with available sizes of DUO Stent implants
• Lesions with intended treatment lengths extending into the IVC
• No safe landing zone at or above the profunda femoral confluence
• Participating in another investigational study in which the subject has not completed the primary endpoint(s)
• Has other comorbidities that, in the opinion of the Investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments