NCT06321575

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

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Avantec Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Golazo® 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.

Timeline

• Start date: 2024-06-20
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-03-20
• Last updated: 2026-02-10

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study