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New treatment option for Peripheral Arterial Disease
Official title The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
ClinicalTrials.gov ID: NCT06321575
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- Age ≥18 years
- Candidate for atherectomy of the peripheral vasculature in the lower limbs
- Life expectancy \>1 year in the opinion of the investigator
- Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise. people with non-compressible arteries shall have a toe brachial index (TBI)...
You likely can't join if
- Active infection in the target limb
- History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days
- Planned surgical or treatment procedure within 30 days after the index procedure
- Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days
- Critical limb ischemia (CLI) with Rutherford clinical classification category 6
- Significant acute or chronic kidney disease with a GFR \<30 and/or requiring dialysis
See the full eligibility criteria
Who can join
- General
- Age ≥18 years
- Candidate for atherectomy of the peripheral vasculature in the lower limbs
- Life expectancy \>1 year in the opinion of the investigator
- Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise. people with non-compressible arteries shall have a toe brachial index (TBI) assessment.
- Target limb Rutherford clinical classification category 3 to 5
- Suitable candidate for angiography and endovascular intervention in the opinion of the investigator
- Willing and able to comply with the protocol-specified procedures and assessments
- Informed consent granted Angiographic
- Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation
- Total treated lesion length ≤20 cm by angiographic visual estimation
- Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation
- Target limb will have a minimum of one patent (less than 50% stenosis) below the knee (BTK) vessel crossing the ankle, distal to any target lesion, providing perfusion to the foot at baseline General
What rules you out
- Active infection in the target limb
- History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days
- Planned surgical or treatment procedure within 30 days after the index procedure
- Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days
- Critical limb ischemia (CLI) with Rutherford clinical classification category 6
- Significant acute or chronic kidney disease with a GFR \<30 and/or requiring dialysis
- Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator
- Myocardial infarction (MI) or stroke within two months of baseline evaluation
- Pregnant or lactating
- Subject is participating in another clinical investigation of a device, drug, or procedure that has not completed the study treatment or that clinically interferes with the endpoints of this study (post-approval...
- Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy
- Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \ 1.5
- Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated
- History of heparin-induced thrombocytopenia (HIT)
- Any thrombolytic therapy within two weeks of enrollment
- Target lesion(s) within a native vessel graft or synthetic graft
- Significant stenosis or occlusion of inflow not successfully treated before the index procedure
- Any evidence or history of intracranial or gastrointestinal bleeding or intracranial aneurysm
- Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
- One or more of the following complications of the foot:
- Osteomyelitis that extends to the metatarsal bones.
- Gangrene involving the plantar skin of the forefoot, midfoot or heel
- Deep ulcer or large shallow ulcer (\>3cm) involving the plantar skin of the forefoot, midfoot, or heel
- Any heel ulcer with/without calcaneal involvement
- Any wound with calcaneal bone involvement
- Wounds that are deemed to be neuropathic or non-ischemic in nature
- Wounds that require flap coverage or complete wound management for large soft tissue defect
- Congestive heart failure with a NYHA functional classification of III or higher Angiographic exclusion criteria:
- More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single tandem lesion
- Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device
- In-stent restenosis within the target lesion(s)
- Potentially unstable or flow-limiting dissection, type C or greater
- Clinical/angiographic evidence of distal embolization
- Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Merced, California, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- Lakeland, Florida, United States
- Miami, Florida, United States
- Thomasville, Georgia, United States
- ‘Aiea, Hawaii, United States
- Baton Rouge, Louisiana, United States
- Houma, Louisiana, United States
- Lafayette, Louisiana, United States
- Plymouth, Massachusetts, United States
- Flemington, New Jersey, United States
- Spartanburg, South Carolina, United States
- Tullahoma, Tennessee, United States
- Beaumont, Texas, United States
- Houston, Texas, United States
- Waco, Texas, United States
- Green Bay, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Merced, California, United States; Fort Lauderdale, Florida, United States; Jacksonville, Florida, United States; Lakeland, Florida, United States; Miami, Florida, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.