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

NCT04793581 | Recruiting FDA Device

• 1 other identifier: IMAGE BTK
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Procedure success

  At 1 day post-procedure

• Freedom from target vessel revascularization (TVR)

  At 6 and 12 months post-procedure

• Primary patency

  At 6 and 12 months post-procedure

• Ankle-Brachial Index (ABI)

  At 6 and 12 months post-procedure

• Rutherford Classificaiton

  At 30 days, 6 months, and 1 year post-procedure

Study Arms (1)

Single Arm

OTHER

Single-arm study

Device: Atherectomy

Interventions

Atherectomy DEVICE

Directional atherectomy of lesions below the knee.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avinger, Inc.: lead

Study Sites (2)

Advanced Cardiac and Vascular Centers

Grand Rapids, Michigan, 49525, United States

RECRUITING

Eastlake Cardiovascular PC

Saint Clair Shores, Michigan, 48080, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 30499198 RESULT

• 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.

  PMID: 28393673 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jaafer Golzar, MD

  Avinger, Inc.

  STUDY CHAIR

Central Study Contacts

Thomas Lawson, PhD

CONTACT

6502417030; tlawson@avinger.com

Ruth Lira, BS

CONTACT

6502417031; rlira@avinger.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: March 11, 2021
• Study Start: January 29, 2021
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)