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Atherectomy Catheter

Treatment Cohort for Peripheral Arterial Disease (INSIGHT Trial)

N/A
Waitlist Available
Led By Sean Janzer, MD
Research Sponsored by Avinger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post treatment procedure
Awards & highlights

Summary

This trial will test a new treatment for blocked arteries in the legs. The goal is to see if it is safe and effective.

Eligible Conditions
  • Peripheral Arterial Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post treatment procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post treatment 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
Freedom from a composite of major adverse events (MAEs) through 30-day follow-up (safety)
Technical success of Pantheris catheter treatment (efficacy) device
Secondary outcome measures
Secondary Effectiveness Endpoint - Ankle-Brachial Index
Secondary Effectiveness Endpoint - Freedom from TLR
Secondary Effectiveness Endpoint - Procedural Success
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment CohortExperimental Treatment1 Intervention
Atherectomy of in-stent restenosis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atherectomy Catheter
2014
N/A
~180

Find a Location

Who is running the clinical trial?

Avinger, Inc.Lead Sponsor
7 Previous Clinical Trials
426 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
322 Patients Enrolled for Peripheral Arterial Disease
Sean Janzer, MDPrincipal InvestigatorEinstein Medical Center
~16 spots leftby Sep 2025
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