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

• ClinicalTrials.gov Identifier: NCT04793581
• Recruitment Status: Recruiting
• First Posted: March 11, 2021
• Last Update Posted: March 29, 2023
• Sponsor: Avinger, Inc.
• Information provided by (Responsible Party): Avinger, Inc.

Tracking Information

• First Submitted Date: January 29, 2021
• First Posted Date: March 11, 2021
• Last Update Posted Date: March 29, 2023
• Actual Study Start Date: January 29, 2021
• Estimated Primary Completion Date: June 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 27, 2023)

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

Original Primary Outcome Measures (submitted: March 8, 2021)

• Major Adverse Events [ Time Frame: from procedure to 30 days post-procedure ]
  freedom from cardiovascular-related events
• Technical success [ Time Frame: At 1 day post-procedure ]
  defined as residual stenosis < 50% after atherectomy

Current Secondary Outcome Measures (submitted: March 27, 2023)

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

Original Secondary Outcome Measures (submitted: March 8, 2021)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of the Utility of the Pantheris Small Vessel (SV) System
• Official Title: Assessment of the Utility of the Pantheris SV System
• 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.
• 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
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Single-arm

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Peripheral Arterial Disease

Intervention

Device: Atherectomy

Directional atherectomy of lesions below the knee.

Study Arms

Single Arm

Single-arm study

Intervention: Device: Atherectomy

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 8, 2021): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2024
• Estimated Primary Completion Date: June 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Thomas Lawson, PhD; 6502417030; tlawson@avinger.com

Contact: Ruth Lira, BS; 6502417031; rlira@avinger.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04793581
• Other Study ID Numbers: IMAGE BTK
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Avinger, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Avinger, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Jaafer Golzar, MD; Avinger, Inc.

• PRS Account: Avinger, Inc.
• Verification Date: March 2023