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Assessment of the Utility of the Pantheris Small Vessel (SV) System
Sponsor: Avinger, Inc.
Summary
A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.
Official title: Assessment of the Utility of the Pantheris SV System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-01-29
Completion Date
2025-08-01
Last Updated
2024-07-30
Healthy Volunteers
No
Conditions
Interventions
Atherectomy
Directional atherectomy of lesions below the knee.
Locations (2)
Advanced Cardiac and Vascular Centers
Grand Rapids, Michigan, United States
Eastlake Cardiovascular PC
Saint Clair Shores, Michigan, United States