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Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon — SWING  

Peripheral Arterial Disease Clinical Trial

Official title:
A Prospective, Multi-Center, Single-Arm, Feasibility Study to Assess the Safety and Performance WIth the SUNDANCE™ DruG Coated Balloon for the Treatment of De Novo or Restenotic Lesions in Infra-Popliteal Arteries

Clinical Trial Summary

To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.

Clinical Trial Description

SWING is a prospective, multi-center, single-arm, feasibility study to assess the safety and performance of the Sundance™ drug coated balloon for the treatment of de novo or restenotic lesions in infra-popliteal Arteries. Approximately 35 subjects will be treated at up to 8 sites. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04107298
Study type Interventional
Source SurModics, Inc.
Contact
Status Completed
Phase N/A
Start date June 29, 2020
Completion date January 30, 2024
View Details
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