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

Sponsor
Angiodynamics, Inc.
Study ID
NCT07472439
Status
Not Yet Recruiting

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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Auryon Atherectomy System — DEVICE
    Auryon Atherectomy System is composed of a laser and catheter
  • Balloon Angioplasty — DEVICE
    Balloon Angioplasty alone

Study Details

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.

Key Dates

First listed
Mar 16, 2026
Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Auryon Atherectomy System and Balloon Angioplasty
    Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty
  • Active Comparator: Balloon Angioplasty Only
    Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only.

Primary Outcome Measure

Win-ratio comparing subjects in the treatment group versus the control group on the components of the composite endpoints in a hierarchical fashion at 12 months [ Time Frame: From enrollment to the end of treatment at 12 month ]

Central Contacts

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