The goal of this clinical investigation is to learn if the Recana Thrombectomy Catheter System can treat chronic venous obstruction and occlusion in participants with symptomatic postthrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are:
1. primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure 2. primary efficacy endpoint: patency greater than or equal to 50 percent (%) lumen diameter achieved during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural)
Participants are screened and qualified for the clinical investigation. Qualified participants (those that meet all eligibility criteria) will undergo treatment with the Recana Thrombectomy Catheter System. Participants are assessed at the following timepoints: 30, 90, 180 and 365 days post-procedure.
Provision of signed and dated informed consent form;
Participant is 18 years of age and older;
Neurologically stable;
Ambulatory;
Comorbidity risks which may limit longevity (<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);
Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;
History of stroke within the last 6 months;
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);