BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease

Inclusion Criteria

• The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
• Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
• The subject is a male or non-pregnant female ≥ 18 years old with an expected lifespan sufficient to allow for completion of all study procedures.
• The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
• The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" ≥ 3 or VCSS pain score of ≥ 2).
• The subject is able and willing to comply with any required medication regimen.
• The reference vessel diameters are between 7mm and 19 mm.

Exclusion Criteria

• Subject is unable or unwilling to provide written informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
• Subject is or plans to become pregnant during the study.
• Subject has contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof and does not meet the venous outflow obstruction requirement or has a malignant obstruction.
• The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <2.
• The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
• The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
• The subject has a known allergy or sensitivity to Nickel or Titanium or intolerance to antiplatelet, anticoagulant or thrombolytic medications medications required per the protocol
• The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
• The subject has any planned surgical interventions within 30 days prior to, or within 30 days after the planned study procedure.
• The subject has a lesion or occlusion which cannot be traversed with a guidewire.
• The subject has had prior stenting in the target vessel.
• The subject has iliofemoral venous segments unsuitable for treatment with available sizes of study devices.
• The subject has another medical condition, which may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow completion of study procedures and follow ups.
• The subject is currently participating in an investigational drug, biologic, or another device study.
• The subject is currently on dialysis or has a serum creatinine ≥2.5mg/dl.