RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)
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 post-thrombotic 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: percent (%) lumen gain 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;
• Symptomatic chronic venous insufficiency (CVI), with edema or pain, (CEAP classification of C3 or greater);
• 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
• Target treatment IVC/Common Iliac confluence to the deep veins above the knee.