RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)

Launched by INTERVENE, INC. · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the Recana Thrombectomy Catheter System, which is designed to help treat people who have chronic venous obstruction—a condition where veins in the legs are blocked or narrowed, causing symptoms like swelling and pain. The study aims to find out if this device is safe to use and if it can effectively open up the blocked veins to improve blood flow.

Adults who have ongoing leg vein problems with symptoms such as swelling or pain, and who meet certain medical criteria, may be eligible to join. Participants will receive treatment using the Recana device and will be closely monitored for up to a year after the procedure, with follow-up visits at 1, 3, 6, and 12 months. During these visits, doctors will check for any side effects and measure how much the veins have opened. This study is currently recruiting patients, and those interested should be aware that not everyone qualifies—people with certain health risks or recent surgeries may not be eligible. Overall, this trial offers a chance to try a new treatment that could improve symptoms caused by blocked leg veins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated informed consent form;
• • 2. Participant is 18 years of age and older;
• • 3. Neurologically stable;
• • 4. Ambulatory;
• • 5. Symptomatic chronic venous insufficiency (CVI), with edema or pain, (CEAP classification of C3 or greater);
• • 6. Flow-limiting venous outflow obstruction (\>50%) within the intended target sites, defined by (a) a common femoral vein continuous waveform without respiratory variation on duplex ultrasound, or, (b) complete occlusion of any part of the iliofemoral tract as diagnosed on baseline duplex or axial imaging per local protocol; and
• • 7. Target treatment IVC/Common Iliac confluence to the deep veins above the knee.
• Exclusion Criteria:
• • 1. Comorbidity risks which may limit longevity (\<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);
• • 2. Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;
• • 3. History of stroke within the last 6 months;
• • 4. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period (i.e., known thrombophilia) including Heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);
• • 5. Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks of consent;
• • 6. Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months of consent;
• • 7. Inadequate inflow in the opinion of the investigator, that cannot be improved to the target vessel;
• • 8. Flow-limiting venous outflow obstruction central to the target/treatment vessel that cannot be treated;
• • 9. Pregnant and/or breastfeeding;
• • 10. Patients with cognitive impairments who are unable to be consented;
• • 11. Patient is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;
• • 12. COPD or similar conditions (lung cancer, pulmonary hypertension, prior major lung surgery, emphysema, O2 dependency) that may, in the opinion of the investigator result in higher pulmonary risk; and
• • 13. Patients considered to belong to a vulnerable population.