Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-OUS)

This is an interventional treatment trial for Chronic Venous Insufficiency Read More

Inclusion Criteria:

• Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
• Failed compression therapy of at least 6 months' duration;
• Deep system venous reflux characterized by >1 second reflux time;
• Presence of at least one target site within the target vessel.

Exclusion Criteria:

• Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
• Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
• Significant peripheral arterial disease with an ankle-brachial index of <0.50 or with incompressible vessels;
• Acute deep venous thrombosis (DVT) within 3 months of consent;
• History of stroke within the last 6 months;
• Flow-limiting venous outflow obstruction central to the intended target sites;
• Insufficient inflow through the treatment vein upon manual augmentation;
• Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
• Chronic renal insufficiency with creatinine level of ≥2mg/dL;
• Hemoglobin level <9.0 mg/dL;
• Platelet count <50,000 or >1,000,000 per mm3;
• Total white blood cell count <3,000/mm3;
• Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
• Non-ambulatory patients;