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

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 insuSciency (CVI), with edema or pain, (CEAPclassification 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 respiratoryvariation on duplex ultrasound, or, (b) complete occlusion of any part of theiliofemoral tract as diagnosed on baseline duplex or axial imaging per localprotocol; 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), wouldpreclude open surgery, or would significantly increase risk for venousthrombo-embolism (VTE);

2. Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of theprocedure;

3. History of stroke within the last 6 months;

4. Known hypercoagulable states that, in the opinion of the Investigator, cannot bemedically managed throughout the study period (i.e., known thrombophilia) includingHeparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);

5. Interventional procedure in the deep venous system (including stent placement) inthe target limb or outflow vessels within 6 weeks of consent;

6. Acute deep venous thrombosis (DVT) in the index limb (not previously observed in thethrombus bearing segment) within 3 months of consent;

7. Inadequate inflow in the opinion of the investigator, that cannot be improved to thetarget vessel;

8. Flow-limiting venous outflow obstruction central to the target/treatment vessel thatcannot 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 theInvestigator, may conflict with this study or compromise study results;

12. COPD or similar conditions (lung cancer, pulmonary hypertension, prior major lungsurgery, emphysema, O2 dependency) that may, in the opinion of the investigatorresult in higher pulmonary risk; and

13. Patients considered to belong to a vulnerable population.