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Study of the Pantheris SV System for Peripheral Arterial Disease

This study is looking at how well a device called the Pantheris SV system works to treat peripheral arterial disease (PAD) in arteries below the knee. PAD is a condition where narrowed arteries reduce blood flow to your limbs. The Pantheris SV system uses a procedure called atherectomy, which removes plaque from your arteries. This study will enroll about 60 participants who are 18 years or older and have PAD in their lower legs. Doctors will measure how much the arteries open up after the procedure and will also track any side effects and how your symptoms change over time. The study is currently unclear about its recruitment status.

Study design
This is a single-arm study, meaning all participants receive the Pantheris SV atherectomy. It plans to enroll about 60 participants.
What's involved
You would undergo the atherectomy procedure. Your symptoms and any side effects would be checked at 30 days, 6 months, and 1 year after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for 30 days after the procedure, and for symptoms and adverse events at 30 days, 6 months, and 1 year after the procedure.

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NCT04793581

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

UNKNOWN
NAAges 18+InterventionalTreatment
Avinger, Inc.
~60 participants
Updated 2024-07-30 on ClinicalTrials.gov
What's tested:Atherectomy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major Adverse Events
Measured over from procedure to 30 days post-procedure
+1 more outcome measured

Conditions

Peripheral Arterial Disease

Explore related trials

Peripheral Artery Disease

Where it's being run

2 sites across 1 states
Michigan2

Study leadership

  • Jaafer Golzar, MD · STUDY_CHAIR · Avinger, Inc.

Who to contact

Thomas Lawson, PhD
[email protected]
6502417030
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Major Adverse Eventsfrom procedure to 30 days post-procedure

    freedom from cardiovascular-related events

  • Technical successAt 1 day post-procedure

    defined as residual stenosis \< 50 percent after atherectomy