The GREAT Trial: Golazo® Peripheral Atherectomy System for Peripheral Arterial Disease
This study is testing the Golazo® Peripheral Atherectomy System, a device used to clear blockages in blood vessels, for people with peripheral arterial disease (PAD). PAD affects blood flow to your limbs, often causing pain. The study aims to see if this system is safe and effective in 159 participants across the U.S. You might be able to join if you are at least 18 years old, need atherectomy in your lower limbs, and have a life expectancy of over one year. Success in this study means participants don't experience major problems during or shortly after the procedure, and the procedure itself is technically successful. The current recruitment status is unclear.
- Study design
- This is a single-arm study, meaning all 159 participants will receive the Golazo® Peripheral Atherectomy System. It is an open-label study, so both you and your doctors will know what treatment you are receiving.
- What's involved
- You would undergo atherectomy treatment with the Golazo® Peripheral Atherectomy System. You will then be followed for 6 months after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
At a glance
Conditions
Where it's being run
20 sites across 12 statesStudy leadership
- Matthew Finn, MD · PRINCIPAL_INVESTIGATOR · Cardiovascular Institute of the South
- Craig Walker, MD · PRINCIPAL_INVESTIGATOR · Cardiovascular Institute of the South
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Freedom from major adverse events (MAE)Index procedure through 30-day follow-up
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
- Technical successDuring surgery/procedure
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