Assessment of the Utility of the Pantheris Small Vessel (SV) System
Recruiting
N/A
Interventional Study
Peripheral Arterial Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Avinger, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* if female, is pregnant or breast feeding
* has had surgery or endovascular …
Contacts