NCT04107298

Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: SurModics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Peripheral Arterial Disease
• Critical Lower Limb Ischemia

Interventions

Type	Name	Description
DEVICE	SUNDANCE™ Drug Coated Balloon	Angioplasty procedure with a sirolimus-coated, percutaneous transluminal angioplasty (PTA) balloon catheter

Timeline

• Start date: 2020-06-29
• Primary completion: 2021-08-23
• Completion: 2024-01-30
• First posted: 2019-09-27
• Last updated: 2024-02-14

Locations

8 sites across 5 countries: Australia, Austria, Germany, Latvia, New Zealand

Regulatory

• FDA-regulated device study