Assessment of the Utility of the Pantheris Small Vessel (SV) System

Status unconfirmed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT04793581

Run by

Avinger, Inc.

People needed

60

Starts

2021-01-29

Expected to finish

2025-08-01

Last updated by the study team

2024-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Advanced Cardiac and Vascular Centers — Grand Rapids, Michigan, United States (enrolling)
• Eastlake Cardiovascular PC — Saint Clair Shores, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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