NCT06777901

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

Randomized Controlled Trial of the Auryon Atherectomy System Used in Combination With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Angiodynamics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Up to 1500 subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for, and be enrolled in, the observational study.

Conditions

• Peripheral Arterial Diseases

Interventions

Type	Name	Description
DEVICE	Auryon Atherectomy System	Auryon Atherectomy System is composed of a laser and catheter
DEVICE	Balloon Angioplasty	Balloon Angioplasty alone

Timeline

• Start date: 2025-04-21
• Primary completion: 2029-02-01
• Completion: 2029-04-01
• First posted: 2025-01-16
• Last updated: 2026-01-08

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study