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NCT06777901 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Peripheral Arterial Diseases, sponsored by Angiodynamics.

Recruiting
Registry status
Phase 4
Development phase
224
Enrollment target
9
Study locations

NCT06777901: Recruiting Phase 4 study of Peripheral Arterial Diseases, sponsored by Angiodynamics.

NCT06777901 is a Phase 4 study of Peripheral Arterial Diseases that is actively recruiting participants, run by Angiodynamics. The registered enrollment target is 224 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06777901, a Phase 4 study of Peripheral Arterial Diseases, is actively recruiting participants, sponsored by Angiodynamics.

RECRUITING
Registry status
Phase 4
Development phase
224 participants
Enrollment target
9
Study locations

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.

Primary Outcome

The primary endpoint will be analyzed based on a Finkelstein-Schoenfeld/win-ratio approach, comparing pairs of subjects on the components of the composite endpoint in a hierarchical fashion: 1. Freedom from amputation 2. Freedom from CD-TLR 3. Primary Patency

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
Angiodynamics

12 total trials

What NCT06777901 shows while recruiting

NCT06777901 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).

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.

NCT06777901 lists 9 locations in 9 states (Arizona, California, Louisiana).

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.

What interventions are being tested in trial NCT06777901?

The interventions under investigation include: Auryon Atherectomy System (DEVICE), Balloon Angioplasty (DEVICE).

Who is sponsoring clinical trial NCT06777901?

This trial is sponsored by Angiodynamics, which has 12 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Peripheral Arterial Diseases

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06777901's enrollment target sits among peer trials

224 379th of 2000 higher than 1,619 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06777901, the US trial registry maintained by the National Library of Medicine. NCT06777901 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.