Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 4

Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone

NCT06777901 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.

Interventions

  • DEVICE Auryon Atherectomy System
  • DEVICE Balloon Angioplasty

Study Locations (9)

Arizona

  • Abrazo Arizona Heart Hospital — Phoenix

California

  • Kaiser Permanente — San Diego

Louisiana

  • CIS Grey ASC — Gray

Maryland

  • MedStar Health Research Institute — Baltimore

Massachusetts

  • Massachusetts General Hospital — Boston

Missouri

  • The Washington University — St Louis

North Carolina

  • University of North Carolina Chapel Hill — Chapel Hill

Ohio

  • University Hospitals Cleveland Medical Center — Cleveland

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2025-04-21
Est. Completion 2029-04
Phase Phase 4

Sponsor

Angiodynamics

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06777901

The ClinicalTrials.gov registry entry for NCT06777901 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Angiodynamics, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Peripheral Arterial Diseases appearing as the primary indexed condition, and to 2 interventions — of which Auryon Atherectomy System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06777901 reports 9 study locations spanning 9 distinct geographic areas — top geographies include Arizona, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06777901 about?

NCT06777901 is a clinical study titled "Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone". The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, am...

What is the current status of trial NCT06777901?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 224 participants. The study started on 2025-04-21. Estimated completion is 2029-04.

What conditions does trial NCT06777901 study?

This clinical trial studies the following conditions: Peripheral Arterial Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06777901?

The interventions under investigation include: Auryon Atherectomy System (DEVICE), Balloon Angioplasty (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06777901?

This trial is sponsored by Angiodynamics, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06777901 being conducted?

This trial has 9 study locations across Arizona, California, Louisiana, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial