The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial) (NCT06321575) | Clinical Trial Compass
RecruitingNot Applicable
The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
United States159 participantsStarted 2024-06-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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. Subjects 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
Exclusion criteria
✕. 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 interventional procedure within 30 days after the index procedure
✕. Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days
✕. 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