Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon

NACompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

June 29, 2020

Primary Completion Date

August 23, 2021

Study Completion Date

January 30, 2024

Conditions

Peripheral Arterial DiseaseCritical Lower Limb Ischemia

Interventions

DEVICE

SUNDANCE™ Drug Coated Balloon

Angioplasty procedure with a sirolimus-coated, percutaneous transluminal angioplasty (PTA) balloon catheter

Trial Locations (8)

Royal Perth Hospital, Perth

Prince of Wales Private Hospital, Randwick

Royal North Shore Hospital, St Leonards

Universitäts Klinikum Graz, Graz

Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen

MEDINOS Kliniken des Landkreises Sonneberg GmbH, Sonneberg

Paul Stradins University Hospital, Riga

Auckland City Hospital, Auckland

All Listed Sponsors

lead

SurModics, Inc.

INDUSTRY

NCT04107298 - Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon | Biotech Hunter | Biotech Hunter