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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Avinger, Inc.
Study ID
NCT04793581
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atherectomy — DEVICE
    Directional atherectomy of lesions below the knee.

Study Details

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.

Key Dates

Start date
Jan 29, 2021
Status verified
Jul 2024
Primary completion
Feb 1, 2025
Completion
Aug 1, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm
    Single-arm study

Primary Outcome Measure

Major Adverse Events [ Time Frame: from procedure to 30 days post-procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Advanced Cardiac and Vascular CentersGrand RapidsMichigan49525
Abby Mize, BS
[email protected]
616-447-8220
Jihad Mustapha, MD (PRINCIPAL_INVESTIGATOR)
Eastlake Cardiovascular PCSaint Clair ShoresMichigan48080
Rewaa Yas, MS
[email protected]
586-944-2800
Thomas Davis, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Grand Rapids, MI

By research site
Advanced Cardiac and Vascular Centers· Grand Rapids, MIEastlake Cardiovascular PC· Saint Clair Shores, MI

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