Recruiting

Pantheris SV

Sponsor:

Avinger, Inc.

Code:

NCT04793581

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atherectomy

Study Details

Brief 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.

Conditions

Peripheral Arterial Disease

Study ID

NCT04793581

Start date

Jan 29, 2021

Status verified date

Jul, 2024

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Feb 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single Arm

Single-arm study

Interventions

Atherectomy

Directional atherectomy of lesions below the knee.

Primary outcome measure

  • Major Adverse Events [ Time Frame: from procedure to 30 days post-procedure ]
  • Technical success [ Time Frame: At 1 day post-procedure ]

Central Contacts and Locations

Central contacts

Thomas Lawson, PhD

6502417030tlawson@avinger.com

Ruth Lira, BS

6502417031rlira@avinger.com

Locations

Advanced Cardiac and Vascular Centers

Recruiting

Grand Rapids, Michigan, United States, 49525

Contacts

Abby Mize, BS

616-447-8220amize@acvcenters.com

Principal Investigator:

Jihad Mustapha, MD

Eastlake Cardiovascular PC

Recruiting

Saint Clair Shores, Michigan, United States, 48080

Contacts

Rewaa Yas, MS

586-944-2800ryas@eastlakecv.com

Principal Investigator:

Thomas Davis, MD

More Information

Sponsor

Avinger, Inc.

Last update posted

Jul 30, 2024

Last verified

Jul, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Avinger, Inc. on 2024-07-30.