Status:
RECRUITING
Assessment of the Utility of the Pantheris Small Vessel (SV) System
Lead Sponsor:
Avinger, Inc.
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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- an...
Detailed Description
This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extrem...
Eligibility Criteria
Inclusion
- 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
Exclusion
- if female, is pregnant or breast feeding
- has had surgery or endovascular procedure within 30 days prior to the index procedure
- has planned surgery within 30 days after the index procedure
- had a major bleeding event within 60 days prior to the index procedure
- currently in the treatment phase of a drug or device trial
- has anticipated life span of less than 1.5 years
- is unwilling to present to the investigator at 30 days, 6 moths, or 1 year after the index procedure
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04793581
Start Date
January 29 2021
End Date
August 1 2025
Last Update
July 30 2024
Active Locations (2)
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1
Advanced Cardiac and Vascular Centers
Grand Rapids, Michigan, United States, 49525
2
Eastlake Cardiovascular PC
Saint Clair Shores, Michigan, United States, 48080