The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIntervene, Inc.

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

Treatment groups

87 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators