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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAngiodynamics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Age of subject is ≥ 18.

Estimated life expectancy ≥1 year.

Subject is able and willing to comply with all assessments in the study.

Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.

Disqualifiers

Target lesion is in a vessel graft or synthetic graft.

Treatment of target lesion with radial access.

Planned target limb major amputation (above-the-ankle).

Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.

Trial design

Treatments tested in this trial

  • Auryon Atherectomy System
  • Balloon Angioplasty

Treatment groups

224 Participants
are divided into 2 treatment groups

Sponsors and collaborators