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

Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries

The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.

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