Actively Recruiting
Assessment of the Utility of the Pantheris Small Vessel (SV) System
Led by Avinger, Inc. · Updated on 2024-07-30
60
Participants Needed
2
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of the Utility of the Pantheris Small Vessel (SV) System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- If female, is pregnant or breast feeding
- 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 months, or 1 year after the index procedure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Advanced Cardiac and Vascular Centers
Grand Rapids, Michigan, United States, 49525
Actively Recruiting
2
Eastlake Cardiovascular PC
Saint Clair Shores, Michigan, United States, 48080
Actively Recruiting
Research Team
T
Thomas Lawson, PhD
CONTACT
R
Ruth Lira, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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