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

Assessment of the Utility of the Pantheris SV System

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Atherectomy

Detailed Description

This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary by the physician, and then adverse events and symptom resolution will be documented at 30 days, 6 months, and 1 year after the procedure. Primary safety endpoints are related to adverse events and will be assessed at the time of the procedure and at 30 days after the procedure. Effectiveness endpoints center on restoration of blood flow.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Lawson, PhD; Phone Number: 6502417030; Email: tlawson@avinger.com
• Study Contact Backup: Name: Ruth Lira, BS; Phone Number: 6502417031; Email: rlira@avinger.com

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Recruiting
      • Advanced Cardiac and Vascular Centers
      • Contact: Abby Mize, BS; Phone Number: 616-447-8220; Email: amize@acvcenters.com
      • Principal Investigator: Jihad Mustapha, MD
    • Saint Clair Shores, Michigan, United States, 48080
      • Recruiting
      • Eastlake Cardiovascular PC
      • Principal Investigator: Thomas Davis, MD
      • Contact: Rewaa Yas, MS; Phone Number: 522 586-944-2800; Email: ryas@eastlakecv.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; Single-arm study	Device: Atherectomy; Directional atherectomy of lesions below the knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events	freedom from cardiovascular-related events	from procedure to 30 days post-procedure
Technical success	defined as residual stenosis < 50 percent after atherectomy	At 1 day post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from target vessel revascularization (TVR)	revascularization needed further	At 6 and 12 months post-procedure
Primary patency	change in peak systolic velocity ratio (PSVR)	At 6 and 12 months post-procedure
Rutherford Classificaiton	Change since index procedure	At 30 days, 6 months, and 1 year post-procedure
Procedure success	defined as residual stenosis < 30 percent post adjunctive therapy	At 1 day post-procedure
Ankle-Brachial Index (ABI)	change since index procedure	At 6 and 12 months post-procedure

Collaborators and Investigators

• Sponsor: Avinger, Inc.
• Investigators: Study Chair: Jaafer Golzar, MD, Avinger, Inc.

Publications and helpful links

General Publications

• Khalili H, Jeon-Slaughter H, Armstrong EJ, Baskar A, Tejani I, Shammas NW, Prasad A, Abu-Fadel M, Brilakis ES, Banerjee S. Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):488-493. doi: 10.1002/ccd.27897. Epub 2018 Nov 30.
• Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: peripheral artery disease (PAD) below-the-knee atherectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: IMAGE BTK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No