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

Primary Purpose

Peripheral Arterial Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Atherectomy

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral artery disease (PAD) below-the-knee atherectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Advanced Cardiac and Vascular CentersRecruiting
Eastlake Cardiovascular PCRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Single-arm study

Outcomes

Primary Outcome Measures

Major Adverse Events

freedom from cardiovascular-related events

Technical success

defined as residual stenosis < 50 percent after atherectomy

Secondary Outcome Measures

Procedure success

defined as residual stenosis < 30 percent post adjunctive therapy

Freedom from target vessel revascularization (TVR)

revascularization needed further

Primary patency

change in peak systolic velocity ratio (PSVR)

Ankle-Brachial Index (ABI)

change since index procedure

Rutherford Classificaiton

Change since index procedure

Full Information

NCT ID

NCT04793581

First Posted

January 29, 2021

Last Updated

March 27, 2023

Sponsor

Avinger, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04793581

Brief Title

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

Official Title

Assessment of the Utility of the Pantheris SV System

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 29, 2021 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avinger, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-arm

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Other

Arm Description

Single-arm study

Intervention Type

Device

Intervention Name(s)

Atherectomy

Intervention Description

Directional atherectomy of lesions below the knee.

Primary Outcome Measure Information:

Title

Major Adverse Events

Description

freedom from cardiovascular-related events

Time Frame

from procedure to 30 days post-procedure

Title

Technical success

Description

defined as residual stenosis < 50 percent after atherectomy

Time Frame

At 1 day post-procedure

Secondary Outcome Measure Information:

Title

Procedure success

Description

defined as residual stenosis < 30 percent post adjunctive therapy

Time Frame

At 1 day post-procedure

Title

Freedom from target vessel revascularization (TVR)

Description

revascularization needed further

Time Frame

At 6 and 12 months post-procedure

Title

Primary patency

Description

change in peak systolic velocity ratio (PSVR)

Time Frame

At 6 and 12 months post-procedure

Title

Ankle-Brachial Index (ABI)

Description

change since index procedure

Time Frame

At 6 and 12 months post-procedure

Title

Rutherford Classificaiton

Description

Change since index procedure

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Lawson, PhD

Phone

6502417030

tlawson@avinger.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ruth Lira, BS

Phone

6502417031

rlira@avinger.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaafer Golzar, MD

Organizational Affiliation

Avinger, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Advanced Cardiac and Vascular Centers

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49525

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abby Mize, BS

Phone

616-447-8220

amize@acvcenters.com

First Name & Middle Initial & Last Name & Degree

Jihad Mustapha, MD

Facility Name

Eastlake Cardiovascular PC

City

Saint Clair Shores

State/Province

Michigan

ZIP/Postal Code

48080

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rewaa Yas, MS

Phone

586-944-2800

Ext

522

ryas@eastlakecv.com

First Name & Middle Initial & Last Name & Degree

Thomas Davis, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30499198

Citation

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.

Results Reference

result

PubMed Identifier

28393673

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, 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.

Results Reference

result

Learn more about this trial

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

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