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: 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. Qualifed 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);
Single group
Recana Thrombectomy Catheter System
Devicerecanalization and debulking of obstructions and occlusions within stented and non-stented segments in veins
Primary Safety Endpoint - Rates of all Adverse Events through 30-days post-index procedure
The primary safety objective is procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
Primary Efficacy Endpoint - Percent Lumen Gain in the Treated Vessel measured at time of procedure
The primary efficacy assessment is 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)
Assessment of patency (using DUS) in the treated vessel
Assessment of the treated venous segment patency (as defined by absence of occlusion and CD-TLR \[clinically-driven target lesion revascularization\]) at 30 days by DUS compared to baseline
Assessment of primary patency (defined as absence of occlusion and CD-TLR [clinically-driven target lesion revascularization]) in the vessel segment at all timepoints
Assessment of primary patency (as defined by absence of occlusion and CD-TLR) of the stented vessel segment via DUS comparison at post procedure and all follow ups 30-days, 90-days, 180-days and 365-days post-procedure
Assessment of secondary patency (defined as absence of occlusion and CD-TLR [clinically-driven target lesion revascularization]) in the stented vessel segment at all timepoints
Assessment of secondary patency (as defined by absence of occlusion and CD-TLR) of the stented segment via DUS at all follow-ups 30-days, 90-days, 180-days and 365-days post-procedure
Assessment of changes in Villalta Score at all timepoints
Assessment of changes in the Villalta Score (Baseline through 365 days post-procedure); the score is a composite based on a rating score of absent (0), mild (1), moderate (2) and severe (3) for symptoms and clinical signs, and presence or absence of venous ulcers. A higher Villalta Score would indicate a worse outcome
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