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Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon

NCT04107298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-02-14

No results posted yet for this study

Summary

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

Conditions

  • Peripheral Arterial Disease
  • Critical Lower Limb Ischemia

Interventions

DEVICE

SUNDANCE™ Drug Coated Balloon

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

Sponsors & Collaborators

  • SurModics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2021-08-23
Completion
2024-01-30
FDA Device
Yes

Countries

  • Australia
  • Austria
  • Germany
  • Latvia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107298 on ClinicalTrials.gov