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.
Active infection in the target limb
History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days
Planned surgical or interventional procedure within 30 days after the index procedure
Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days
Avantec Vascular
Lead sponsor
Bright Research Partners
Collaborator
Yale Cardiovascular Research Group
Collaborator