RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Assessment of the Utility of the Pantheris SV System

Quick Facts

Study Start:2021-01-29
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04793581

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Target lesion in the infragenicular segment
  3. * At least 1 pedal vessel noted in the foot
  4. * Rutherford classification 3 to 6
  5. * Willing to give informed consent
  1. * if female, is pregnant or breast feeding
  2. * has had surgery or endovascular procedure within 30 days prior to the index procedure
  3. * has planned surgery within 30 days after the index procedure
  4. * had a major bleeding event within 60 days prior to the index procedure
  5. * currently in the treatment phase of a drug or device trial
  6. * has anticipated life span of less than 1.5 years
  7. * is unwilling to present to the investigator at 30 days, 6 moths, or 1 year after the index procedure

Contacts and Locations

Study Contact

Thomas Lawson, PhD
CONTACT
6502417030
tlawson@avinger.com
Ruth Lira, BS
CONTACT
6502417031
rlira@avinger.com

Principal Investigator

Jaafer Golzar, MD
STUDY_CHAIR
Avinger, Inc.

Study Locations (Sites)

Advanced Cardiac and Vascular Centers
Grand Rapids, Michigan, 49525
United States
Eastlake Cardiovascular PC
Saint Clair Shores, Michigan, 48080
United States

Collaborators and Investigators

Sponsor: Avinger, Inc.

  • Jaafer Golzar, MD, STUDY_CHAIR, Avinger, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-29
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2021-01-29
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

  • peripheral artery disease (PAD) below-the-knee atherectomy

Additional Relevant MeSH Terms

  • Peripheral Arterial Disease