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Atherectomy Device

Atherectomy for Peripheral Artery Disease

N/A
Recruiting
Research Sponsored by Avinger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
At least 1 pedal vessel noted in the foot
Must not have
Has planned surgery within 30 days after the index procedure
If female, is pregnant or breast feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days, 6 months, and 1 year post-procedure
Awards & highlights

Summary

This trial studies a tool to treat peripheral artery disease in leg arteries. Results will be tracked over 1 year and safety monitored.

Who is the study for?
This trial is for adults with Peripheral Arterial Disease affecting arteries below the knee, who have at least one blood vessel visible in the foot and are experiencing moderate to severe symptoms. Pregnant or breastfeeding women, recent surgery patients, those with major bleeding events, or individuals involved in other drug/device trials cannot participate.
What is being tested?
The study is testing the Pantheris SV catheter's effectiveness in treating artery blockages below the knee. Participants will undergo atherectomy and be monitored for changes in artery narrowing before and after treatment as well as any symptoms or complications up to one year post-procedure.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort at the catheter insertion site, bleeding, risk of infection, possible damage to blood vessels during atherectomy, and general risks associated with medical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have at least one blood vessel visible in my foot.
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My target lesion is below the knee.
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My leg pain is severe, affecting my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for surgery within 30 days after my initial procedure.
Select...
I am not pregnant or breastfeeding.
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I had a significant bleeding event within the last 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 and 12 months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 and 12 months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major Adverse Events
Technical success
Secondary outcome measures
Ankle-Brachial Index (ABI)
Freedom from target vessel revascularization (TVR)
Primary patency
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Single-arm study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atherectomy
2020
N/A
~110

Find a Location

Who is running the clinical trial?

Avinger, Inc.Lead Sponsor
7 Previous Clinical Trials
493 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
389 Patients Enrolled for Peripheral Arterial Disease
Jaafer Golzar, MDStudy ChairAvinger, Inc.
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
250 Patients Enrolled for Peripheral Arterial Disease

Media Library

Pantheris SV catheter (Atherectomy Device) Clinical Trial Eligibility Overview. Trial Name: NCT04793581 — N/A
Peripheral Arterial Disease Research Study Groups: Single Arm
Peripheral Arterial Disease Clinical Trial 2023: Pantheris SV catheter Highlights & Side Effects. Trial Name: NCT04793581 — N/A
Pantheris SV catheter (Atherectomy Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04793581 — N/A
~5 spots leftby Feb 2025
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