Assessment of the Utility of the Pantheris SV System
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years or older
• Target lesion in the infragenicular segment
• At least 1 pedal vessel noted in the foot
• Rutherford classification 3 to 6
• Willing to give informed consent
Locations
United States
Michigan
Advanced Cardiac and Vascular Centers
RECRUITING
Grand Rapids
Eastlake Cardiovascular PC
RECRUITING
Saint Clair Shores
Contact Information
Primary
Thomas Lawson, PhD
tlawson@avinger.com
6502417030
Backup
Ruth Lira, BS
rlira@avinger.com
6502417031
Time Frame
Start Date: 2021-01-29
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 60
Treatments
Other: Single Arm
Single-arm study
Related Therapeutic Areas
Sponsors
Leads: Avinger, Inc.