Actively Recruiting
The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
Led by Avantec Vascular · Updated on 2026-02-10
159
Participants Needed
20
Research Sites
123 weeks
Total Duration
On this page
Sponsors
A
Avantec Vascular
Lead Sponsor
B
Bright Research Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Candidate for atherectomy of the peripheral vasculature in the lower limbs
- Life expectancy greater than 1 year as judged by the investigator
- Resting ankle brachial index (ABI) of 0.90 or less, or 0.75 or less after exercise; toe brachial index (TBI) if arteries are non-compressible
- Target limb Rutherford clinical classification category 3 to 5
- Suitable candidate for angiography and endovascular intervention as judged by the investigator
- Willing and able to comply with study procedures and assessments
- Signed informed consent
- Target lesion(s) with 70% or greater stenosis by angiographic visual estimation
- Total treated lesion length 20 cm or less by angiographic visual estimation
- Target vessel diameter between 2.0 mm and 4.5 mm by angiographic visual estimation
- Target limb has at least one patent below the knee vessel crossing the ankle providing foot perfusion at baseline
You will not qualify if you...
- Active infection in the target limb
- History of endovascular or open vascular surgery on the target limb within the last 30 days
- Planned surgical or interventional procedure within 30 days after the index procedure
- Lesion in the opposite limb requiring intervention during or within 30 days after the procedure
- Critical limb ischemia with Rutherford category 6
- Significant kidney disease with GFR less than 30 or requiring dialysis
- Acute myocardial infarction or uncontrolled comorbidity as judged by investigator
- Myocardial infarction or stroke within 2 months before screening
- Pregnant or breastfeeding
- Participation in another clinical study with incomplete treatment or conflicting endpoints
- Contraindications to antiplatelet, anticoagulant, or thrombolytic therapy
- Uncorrectable bleeding disorders, platelet dysfunction, thrombocytopenia below 125,000/microliter, or INR above 1.5
- Allergy to contrast agents or medications used in endovascular intervention that cannot be treated
- History of heparin-induced thrombocytopenia
- Thrombolytic therapy within 2 weeks before enrollment
- Target lesion within a native or synthetic graft
- Untreated significant stenosis or occlusion of inflow vessels
- History or evidence of intracranial or gastrointestinal bleeding or aneurysm
- Vulnerable populations such as incarcerated or cognitively challenged adults
- Foot complications including osteomyelitis extending to metatarsal bones, gangrene of plantar skin, deep or large ulcers over 3 cm on plantar skin, heel ulcers with or without bone involvement, wounds requiring flap coverage, neuropathic or non-ischemic wounds
- Congestive heart failure with NYHA class III or higher
- More than 2 lesions to be treated or lesions within 3 mm not considered as single tandem lesion
- Clinical or angiographic complications related to other devices prior to investigational device use
- In-stent restenosis within target lesion(s)
- Unstable or flow-limiting dissections type C or greater
- Evidence of distal embolization
- Inability to cross the lesion with a guidewire
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
Pulse Cardiovascular Institute
Scottsdale, Arizona, United States, 85251
Actively Recruiting
3
Merced Vascular
Merced, California, United States, 95340
Actively Recruiting
4
Palm Vascular Center
Fort Lauderdale, Florida, United States, 33312
Actively Recruiting
5
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32256
Actively Recruiting
6
Radiology and Imaging Specialists of Lakeland
Lakeland, Florida, United States, 33801
Completed
7
Amavita Research Services
Miami, Florida, United States, 33137
Actively Recruiting
8
Cardiovascular Consultants of South Georgia
Thomasville, Georgia, United States, 31792
Actively Recruiting
9
Pacific Vascular Institute
‘Aiea, Hawaii, United States, 96701
Actively Recruiting
10
Baton Rouge General Hospital
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
11
Cardiovascular Institute of the South - Houma
Houma, Louisiana, United States, 70360
Actively Recruiting
12
Cardiovascular Institute of the South - Lafayette
Lafayette, Louisiana, United States, 70506
Actively Recruiting
13
Vascular Breakthroughs
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
14
Advanced Heart and Vascular Institute
Flemington, New Jersey, United States, 08822
Actively Recruiting
15
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
16
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States, 37388
Actively Recruiting
17
Nextstage Clinical Research - Beaumont
Beaumont, Texas, United States, 77702
Actively Recruiting
18
Hope Vascular & Podiatry
Houston, Texas, United States, 77054
Actively Recruiting
19
Nextstage Clinical Research - Waco
Waco, Texas, United States, 76712
Actively Recruiting
20
Bellin Health
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
Research Team
G
Gene Reu
CONTACT
J
Jessi Maumee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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