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.
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.
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.
Parallel
Auryon Atherectomy System
DeviceAuryon Atherectomy System is composed of a laser and catheter
Balloon Angioplasty
DeviceBalloon Angioplasty alone
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
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
Device Success
Successful delivery, lesion crossing, functionality and retrieval of the investigational device
Procedural Success
Defined as device success and residual diameter stenosis ≤30% on completion angiography without flow-limiting dissection (≥ grade D), perforation or distal embolization, all assessed by core lab on angiography.
Clinical Success
Defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge.
Secondary Duplex Ultrasound Imaging Measures
Subsegmental analysis: proportion of segments with binary restenosis (diameter stenosis of \>50% or PSVR ≤ 2.5) on core lab-adjudicated DUS.
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