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

NCT07529756 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 87

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Chronic Venous Disease
  • Chronic Venous Insufficiency, CVI
  • Venous Thrombosis
  • Thrombosis (Stent Thrombosis)
  • Thrombosis, Venous
  • Embolism and Thrombosis
  • Thrombectomy

Interventions

DEVICE

Recanalization and debulking

Recanalization and debulking with the Recana Thrombectomy Catheter System

Sponsors & Collaborators

  • Intervene, Inc.

    lead INDUSTRY

Principal Investigators

  • William A Marston, MD · University of North Carolina

  • Kush R Desai, MD · Northwestern University

  • Sameh Sayfo, MD, MBA · Baylor Scott & White The Heart Hospital - Plano

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-12-31
Completion
2029-03-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529756 on ClinicalTrials.gov