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
Single group
Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
DeviceGolazo® Peripheral AS is a sterile, single-use percutaneous device that has two main components: 1) the Golazo® Accustrike atherectomy catheter, and 2) the Golazo® motorized drive unit (MDU) and is intended for use in atherectomy of the peripheral vasculature.
Freedom from major adverse events (MAE)
MAE is defined as: * Clinically-driven target lesion revascularization (CD-TLR) * Cardiovascular-related deaths * Unplanned major target limb amputation (above the ankle) * Perforations or dissections grade C or greater in the target vessel that require intervention * Symptomatic distal emboli requiring intervention * Pseudoaneurysm requiring intervention
Technical success
Defined as the percent of target lesions that have a residual diameter stenosis ≤50% after atherectomy with the Golazo Peripheral AS and prior to adjunctive therapy
Change in % stenosis in target lesion after treatment with Golazo Peripheral AS
Determined after atherectomy and prior to other adjunctive therapies
Procedural Success Rate
Defined as the proportion of the target lesion in which the final stenosis is ≤30% after treatment with atherectomy and any other adjunctive therapy
Clinical Success Rate
Defined as the proportion of subjects who have procedural success in all target lesions with at least one grade of improvement in the Rutherford clinical classification
Rates of all adverse events classified as MAEs
As adjudicated by the CEC and presented by seriousness and causality (procedure and device relatedness)
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Nipro Vascular Innovations Americas, Inc
Lead sponsor
Bright Research, Inc.
Collaborator
Yale Cardiovascular Research Group
Collaborator
