NCT04765566

FLUENCY® PLUS in the Treatment of Peripheral Artery Disease

A Retrospective, Multi-Center, Real World Study of the BD Bard FLUENCY® PLUS Vascular Stent Graft in the Treatment of Peripheral Artery Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 146 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of FLUENCY® PLUS Vascular Stent Graft in iliac artery vessel(s) between January 2010 and March 2020.

Detailed description

The purpose of this study is to retrospectively collect and analyze data on the FLUENCY® PLUS Vascular Stent Graft to summarize and describe real-world experience, and long-term data regarding its safety and efficacy and to compare these findings with published data on stent-treatment in iliac artery disease. The present study aims to collect clinical data about FLUENCY® treatment of atherosclerotic disease (stenosis, occlusion, dissection) as well as to explore safety and effectiveness data for off-label use in additional indications in the iliac segment that have been described in the scientific literature (vessel rupture, aneurysm).

Conditions

• Vascular Diseases, Peripheral

Interventions

Type	Name	Description
DEVICE	Endovascular revascularization of peripheral arteries	Endovascular revascularization of peripheral arteries involves placement of a self-expanding Nitinol Stent encapsulated with ePTFE in diseased vessel segments

Timeline

• Start date: 2021-02-05
• Primary completion: 2021-10-31
• Completion: 2022-02-28
• First posted: 2021-02-21
• Last updated: 2022-04-29

Locations

6 sites across 2 countries: Germany, Poland