Trials / Not Yet Recruiting

Not Yet RecruitingNCT07529756

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

The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry ("The CALIBER Registry")

Status: Not Yet Recruiting
Phase: —
Study type: Observational
Enrollment: 86 (estimated)

Sponsor: Intervene, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

The CALIBER Registry is a prospective, multi-center, non-randomized, non-interventional (observational) registry of the Recana Thrombectomy Catheter System for the treatment of symptomatic venous obstruction and occlusions. Commensurate with the continuum of care and usual practice for the follow-up of the study population, subjects are assessed at post-procedure/discharge, 30-day (30D), 180-day (180D) and 365-day (365D) post-index procedure \[reporting on these timepoints are based on standard of care clinic visits that occur closest to timepoints at 30D, 180D and 365D post-procedure\].

Conditions

Interventions

Type	Name	Description
DEVICE	mechanical thrombectomy	Mechanical thrombectomy with the Recana Thrombectomy Catheter System

Timeline

Start date: 2026-06-01
Primary completion: 2028-12-01
Completion: 2029-03-01
First posted: 2026-04-14
Last updated: 2026-04-14

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT07529756. Inclusion in this directory is not an endorsement.