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.
The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study. Subjects will undergo atherectomy treatment with the Golazo® Peripheral Atherectomy System and will then be followed 6-months post-procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
159
Golazo® 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.
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States
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
Time frame: Index procedure through 30-day follow-up
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
Time frame: During surgery/procedure
Change in % stenosis in target lesion after treatment with Golazo Peripheral AS
Determined after atherectomy and prior to other adjunctive therapies
Time frame: During surgery/procedure
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
Time frame: End of surgery/procedure
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
Time frame: 30-day and 6-month follow-up
Rates of all adverse events classified as MAEs
As adjudicated by the CEC and presented by seriousness and causality (procedure and device relatedness)
Time frame: 30-day and 6-month follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pulse Cardiovascular Institute
Scottsdale, Arizona, United States
RECRUITINGMerced Vascular
Merced, California, United States
RECRUITINGPalm Vascular Center
Fort Lauderdale, Florida, United States
RECRUITINGFirst Coast Cardiovascular Institute
Jacksonville, Florida, United States
RECRUITINGRadiology and Imaging Specialists of Lakeland
Lakeland, Florida, United States
COMPLETEDAmavita Research Services
Miami, Florida, United States
RECRUITINGCardiovascular Consultants of South Georgia
Thomasville, Georgia, United States
RECRUITINGPacific Vascular Institute
‘Aiea, Hawaii, United States
RECRUITINGBaton Rouge General Hospital
Baton Rouge, Louisiana, United States
RECRUITING...and 10 more locations
Incidence of minor target limb amputation
As adjudicated by the CEC
Time frame: 30-day and 6-month follow-up
Incidence of myocardial infarction
As adjudicated by the CEC
Time frame: 30-day and 6-month follow-up
Incidence of target vessel revascularization (TVR) in the target limb
As adjudicated by the CEC
Time frame: 30-day and 6-month follow-up
Incidence of angiographic procedural distal embolization in the target limb
As reported by the angiographic core laboratory
Time frame: During surgery/procedure
Time to primary patency of the target lesion(s)
Primary patency is the interval from the time of the index procedure until the time of any intervention designed to maintain or reestablish patency of the target vessels, the time significant stenosis or total occlusion is confirmed, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
Time frame: 6 months
Time to assisted primary patency of the target lesion(s)
Assisted primary patency is the interval from the time of the index procedure until the time significant stenosis is confirmed, including interventions designed to maintain patency of a vessel with significant stenosis, the time total occlusion is confirmed, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
Time frame: 6 months
Time to secondary patency of the target lesion(s)
Secondary patency is the interval from the time of the index procedure until the time total occlusion is confirmed in a target vessel, including interventions designed to reestablish patency in a total occluded vessel, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
Time frame: 6 months