Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

• Stellarex DCB (Device): Intervention with the Stellarex DCB
• PTA Catheter (Device): Intervention with an uncoated Standard PTA

Primary outcomes

• Freedom from Major Adverse Limb Event (MALE) [30 days]: Composite of major amputation or major reintervention on a per patient basis
• Freedom from Perioperative Death (POD) [30 days]: Death on a per patient basis
• Patency [6 months]: Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
• Limb Salvage [6 months]: Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

Secondary outcomes

• Clinically-driven target lesion revascularization [6 months]: Rate of clinically-driven target lesion revascularization
• Major adverse event rates [6 months]: Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
• Patency rate [6 months]: Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* Rutherford Clinical Category 4-5
* Life expectancy > 1 year
* Significant stenosis ≥70%
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at the ankle

Exclusion Criteria:

* Pregnant or planning to become pregnant
* History of stroke within 3 months
* Planned major amputation
* eGFR <30
* Acute limb ischemia
* Prior stent placement in target lesion

• William Gray, MD, Principal investigator, Lankenau Heart Institute
• Mahmood K Razavi, MD, Principal investigator, Vascular and Interventional Specialists of Orange
• Dierk Scheinert, MD, Principal investigator, University of Leipzig