Clinical Trial

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

Study acronym: AMBITION BTK
Recruiting Phase 4
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-10; most recent amendment 2026-01-07.
Status change: Not Yet Recruiting → Recruiting 2025-05-05
Trial Details
NCT Number NCT06777901
Lead Sponsor Angiodynamics, Inc.
Conditions Peripheral Arterial Diseases
Enrollment 224 participants
Start Date 2025-04-21
Primary Completion 2029-02 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2026-01-08