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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days, 6 months, and 1 year post-procedure

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 and 12 months post-procedure

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

0 / 4Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently underway for this research endeavor?

"Yes, the research is actively enrolling individuals. The original listing of this medical study was on January 29th 2021 and it has been edited as recently as March 27th 2023 according to clinicaltrials.gov."

Answered by AI

How many individuals are being monitored during this trial's duration?

"Affirmative. Clinicaltrials.gov shows that the research, which was introduced on January 29th 2021, is presently looking for volunteers. In total, 60 participants need to be sourced from 2 clinics."

Answered by AI

What objectives does this research endeavor strive to achieve?

"The primary endpoint for this study is Technical Success and will be monitored from the time of procedure to 30 days post-procedure. Secondary endpoints include Procedure success, Rutherford Classification, and Ankle-Brachial Index (ABI)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Assessment of the Utility of the Pantheris Small Vessel (SV) System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04793581.

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