Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

Launched by INTERVENE, INC. · Jul 10, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the BlueLeaf System, which aims to help people with chronic venous insufficiency (CVI). CVI is a condition where the veins in the legs struggle to send blood back to the heart, leading to symptoms like swelling, pain, and discomfort. The trial is looking to see if this new system can safely and effectively improve blood flow in patients who have not found relief from standard compression therapy for at least six months.

To participate in this study, individuals must be between the ages of 65 and 74 and have symptoms of CVI that have not improved with other treatments. They should also have specific issues with blood flow in their veins. However, certain conditions, like recent blood clots or significant heart problems, may prevent someone from joining the trial. Those who take part can expect to receive close monitoring and care throughout the study to ensure their safety and assess how well the treatment works.

Gender

ALL

Eligibility criteria

• 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;