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Trial record 1 of 2 for:    IMAGE BTK
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Assessment of the Utility of the Pantheris Small Vessel (SV) System

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Atherectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Utility of the Pantheris SV System
Actual Study Start Date : January 29, 2021
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : August 1, 2024

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Arms and Interventions
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Arm Intervention/treatment
Single Arm
Single-arm study
 Device: Atherectomy
Directional atherectomy of lesions below the knee.


Outcome Measures
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Primary Outcome Measures :
  1. Major Adverse Events [ Time Frame: from procedure to 30 days post-procedure ]
    freedom from cardiovascular-related events

  2. Technical success [ Time Frame: At 1 day post-procedure ]
    defined as residual stenosis < 50 percent after atherectomy


Secondary Outcome Measures :
  1. Procedure success [ Time Frame: At 1 day post-procedure ]
    defined as residual stenosis < 30 percent post adjunctive therapy

  2. Freedom from target vessel revascularization (TVR) [ Time Frame: At 6 and 12 months post-procedure ]
    revascularization needed further

  3. Primary patency [ Time Frame: At 6 and 12 months post-procedure ]
    change in peak systolic velocity ratio (PSVR)

  4. Ankle-Brachial Index (ABI) [ Time Frame: At 6 and 12 months post-procedure ]
    change since index procedure

  5. Rutherford Classificaiton [ Time Frame: At 30 days, 6 months, and 1 year post-procedure ]
    Change since index procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793581


Contacts
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Contact: Thomas Lawson, PhD 6502417030 tlawson@avinger.com
Contact: Ruth Lira, BS 6502417031 rlira@avinger.com

Locations
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United States, Michigan
Advanced Cardiac and Vascular Centers Recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Abby Mize, BS    616-447-8220    amize@acvcenters.com   
Principal Investigator: Jihad Mustapha, MD         
Eastlake Cardiovascular PC Recruiting
Saint Clair Shores, Michigan, United States, 48080
Contact: Rewaa Yas, MS    586-944-2800 ext 522    ryas@eastlakecv.com   
Principal Investigator: Thomas Davis, MD         
Sponsors and Collaborators
Avinger, Inc.
Investigators
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Study Chair: Jaafer Golzar, MD Avinger, Inc.
More Information
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Publications of Results:

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Responsible Party: Avinger, Inc.
ClinicalTrials.gov Identifier: NCT04793581    
Other Study ID Numbers: IMAGE BTK
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Avinger, Inc.:
peripheral artery disease (PAD) below-the-knee atherectomy
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases