About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Recanalization and debulking