The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions. The main questions the study aims to answer are:
* What is the observed rate of safety events through the 30-day follow-up? * What is the rate of technical success (acute procedural success) achieved at the index procedure?
Participants already undergoing treatment with the Recana as part of their regular medical care will be followed for 1 year.
INC-1: Subject is 18 years or older
INC-2: Proximal lower extremity obstruction/occlusion involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination that in the opinion of the investigator, treatment with the Recana would benefit the patient
INC-3: Recana Thrombectomy Catheter System must enter vasculature
INC-4: Willing and able to provide written informed consent
None
Potential subjects with symptomatic lower extremity obstruction/occlusion
Cohort
Prospective
Recanalization and debulking
DeviceRecanalization and debulking with the Recana Thrombectomy Catheter System
Composite of Major Adverse Events (MAE)
Composite of Major Adverse Events (MAE) where MAE is a combined clinical endpoint of death (all-cause mortality), major bleeding, and symptomatic pulmonary embolism
Technical Success (Acute Procedural Success)
* In-stent restenosis (ISR) venous segment: defined as patency ≥50% luminal diameter utilizing IVUS * Native venous segment: defined as patency ≥50% luminal diameter utilizing IVUS
Incidence rates of the following: (1) Individual components of the MAE composite endpoint; (2) Minor bleeding; and (3) Access site complications from the index procedure (hematoma, false aneurysm, perforation)
Incidence rates (counts) through 30-days of 3 outcome measures: (1) Individual components of the MAE composite endpoint (death (all-cause mortality), major bleeding, and symptomatic pulmonary embolism); (2) Minor bleeding; and (3) Access site complications from the index procedure (hematoma, false aneurysm, perforation).
Incidence rate of device-related death
Incidence rate (count) of any device-related death through 365-days post-procedure.
Incidence rate of procedure-related death
Incidence rate (count) of any procedure-related death through 365-days post-procedure.
Patency rates of Target Venous Segment (TVS)
TVS patency determined by duplex ultrasound or other imaging modality preferred by investigator through 365-days post-procedure.
Additional Safety Outcome Measures through 30-days post-procedure in the Primary Analysis Set (PAS) Population
Incidence rate (count) of device-related serious adverse events (SAEs) that occur through 30-days post-procedure.
Additional Safety Outcome Measures through 365-days post-procedure in the Primary Analysis Set (PAS) Population
Overall rates (count) of the following that occur through 365-days post-procedure: 1. all reported adverse events (AEs) 2. hospital readmission 3. all-cause mortality 4. pulmonary embolism 5. major bleeding caused by vessel perforation
Post-procedural average effective stent diameter (percent) in the Primary Analysis Set (PAS) Population
Post-procedure average effective stent diameter (percent) measured using intravascular ultrasound (IVUS).
Post-procedural average inner lumen area (mm2) in the Primary Analysis Set (PAS) Population
Post-procedural average inner lumen area (mm2) measured using intravascular ultrasound (IVUS).
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