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Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter — SAFE-DCB  

Peripheral Arterial Disease Clinical Trial

Official title:
A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)

Clinical Trial Summary

The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.

Clinical Trial Description

The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02424383
Study type Interventional
Source C. R. Bard
Contact
Status Completed
Phase N/A
Start date April 23, 2015
Completion date October 21, 2019
View Details
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