The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy
Avantec Vascular
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General inclusion criteria: 1. Age ≥18 years 2. Candidate for atherectomy of the peripheral vasculature in the lower limbs 3. Life expectancy \>1 year in the opinion of the investigator 4. 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. 5. Target limb Rutherford clinical classification category 3 to 5 6. Suitable candidate for angiography and endovascular intervention in the opinion of the investigator 7. Willing and able to comply with the protocol-specified procedures and assessments…
Interventions
- DeviceGolazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
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.
Locations (20)
- HonorHealth Scottsdale Osborn Medical CenterScottsdale, Arizona
- Pulse Cardiovascular InstituteScottsdale, Arizona
- Merced VascularMerced, California
- Palm Vascular CenterFort Lauderdale, Florida
- First Coast Cardiovascular InstituteJacksonville, Florida
- Radiology and Imaging Specialists of LakelandLakeland, Florida