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

Peripheral Arterial Disease Clinical Trial

Official title:

Assessment of the Utility of the Pantheris SV System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793581
• Other study ID #: IMAGE BTK
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2023
• Source: Avinger, Inc.
• Contact: Thomas Lawson, PhD
• Phone: 6502417030
• Email: tlawson[@]avinger.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Atherectomy
Directional atherectomy of lesions below the knee.

Locations

Country	Name	City	State
United States	Advanced Cardiac and Vascular Centers	Grand Rapids	Michigan
United States	Eastlake Cardiovascular PC	Saint Clair Shores	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Avinger, Inc.

Country where clinical trial is conducted

United States, 

References & 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. 201 — View Citation

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, Sim — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events	freedom from cardiovascular-related events	from procedure to 30 days post-procedure
Primary	Technical success	defined as residual stenosis < 50 percent after atherectomy	At 1 day post-procedure
Secondary	Procedure success	defined as residual stenosis < 30 percent post adjunctive therapy	At 1 day post-procedure
Secondary	Freedom from target vessel revascularization (TVR)	revascularization needed further	At 6 and 12 months post-procedure
Secondary	Primary patency	change in peak systolic velocity ratio (PSVR)	At 6 and 12 months post-procedure
Secondary	Ankle-Brachial Index (ABI)	change since index procedure	At 6 and 12 months post-procedure
Secondary	Rutherford Classificaiton	Change since index procedure	At 30 days, 6 months, and 1 year post-procedure