Clinical Trial

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

Study acronym: CALIBER
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 1 change
notable Enrollment increased: 87 -> 500 participants 2026-08-04
Trial Details
NCT Number NCT07529756
Lead Sponsor Intervene, Inc.
Conditions Chronic Venous Disease, Chronic Venous Insufficiency, CVI, Venous Thrombosis, Thrombosis (Stent Thrombosis), Thrombosis, Venous, Embolism and Thrombosis, Thrombectomy
Enrollment 500 participants
Start Date 2026-08
Primary Completion 2028-12 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-03