Upstate Active Clinical Trials

Study 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)

What is the purpose of the study? (in Layman's terms, please describe the study)

This patient registry involves the collection of information about the following Bard Peripheral Vascular, Inc. (Bard) peripheral device:

• Lutonix® DCB PTA catheter (Lutonix® DCB)

This device has been approved by the U.S. Food and Drug Administration (FDA). Bard Peripheral Vascular, Inc. is the sponsor of this patient registry. The sponsor has contracted with various hospitals to conduct this registry. As a result, the hospitals are receiving payments and/or other compensation from the sponsor for the conduct of this patient registry.

Upstate Institutional Review Board (IRB) Number:

753609

Study/Protocol ID:

BPV-14-006

Patient Age Group:

Adults

Principal Investigator:

Michael J Costanza

Who can I contact for more information?

Name: Linda J Ellinwood, RN
Phone: 315-464-1852
Email: [email protected]

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