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RecruitingNot ApplicableNCT04793581

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

Assessment of the Utility of the Pantheris SV System

Sponsor

Avinger, Inc.

Enrollment

60 participants

Start Date

Jan 29, 2021

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

DEVICEAtherectomy

Directional atherectomy of lesions below the knee.

Locations(2)

Advanced Cardiac and Vascular Centers

Grand Rapids, Michigan, United States

Eastlake Cardiovascular PC

Saint Clair Shores, Michigan, United States

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NCT04793581

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