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

Description

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

Peripheral Arterial Disease

Study Overview

Study Details

Study overview

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.

Assessment of the Utility of the Pantheris SV System

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

Condition
Peripheral Arterial Disease
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

Advanced Cardiac and Vascular Centers, Grand Rapids, Michigan, United States, 49525

Saint Clair Shores

Eastlake Cardiovascular PC, Saint Clair Shores, Michigan, United States, 48080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avinger, Inc.,

Jaafer Golzar, MD, STUDY_CHAIR, Avinger, Inc.

Study Record Dates

2025-08-01