Study detail
RecruitingObservational
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