The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy
The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.
• Age ≥18 years
• Candidate for atherectomy of the peripheral vasculature in the lower limbs
• Life expectancy \>1 year in the opinion of the investigator
• Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise. Subjects with non-compressible arteries shall have a toe brachial index (TBI) assessment.
• Target limb Rutherford clinical classification category 3 to 5
• Suitable candidate for angiography and endovascular intervention in the opinion of the investigator
• Willing and able to comply with the protocol-specified procedures and assessments
• Informed consent granted
• Angiographic inclusion criteria:
• Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation
⁃ Total treated lesion length ≤20 cm by angiographic visual estimation
⁃ Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation
⁃ Target limb will have a minimum of one patent (less than 50% stenosis) below the knee (BTK) vessel crossing the ankle, distal to any target lesion, providing perfusion to the foot at baseline