The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

Recruiting N/A Interventional Study
Peripheral Arterial Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
159 (estimated)
Sponsor
Avantec Vascular · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 sha…
Contacts

Gene Reu

858-945-0007

GReu@avantecvascular.com

CONTACT

Jessi Maumee

612-345-4544

jessi.maumee@brightresearch.com

CONTACT