The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
- Registration Number
- NCT06321575
- Lead Sponsor
- Avantec Vascular
- Brief 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 15 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 159
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Golazo® Peripheral Atherectomy System Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) Treatment atherectomy of the peripheral vasculature with the Golazo® Peripheral Atherectomy System.
- Primary Outcome Measures
Name Time Method 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 interventionTechnical success During 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
- Secondary Outcome Measures
Name Time Method Incidence of myocardial infarction 30-day and 6-month follow-up As adjudicated by the CEC
Time to primary patency of the target lesion(s) 6 months Primary patency is the interval from the time of the index procedure until the time of any intervention designed to maintain or reestablish patency of the target vessels, the time significant stenosis or total occlusion is confirmed, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
Time to assisted primary patency of the target lesion(s) 6 months Assisted primary patency is the interval from the time of the index procedure until the time significant stenosis is confirmed, including interventions designed to maintain patency of a vessel with significant stenosis, the time total occlusion is confirmed, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
Change in % stenosis in target lesion after treatment with Golazo Peripheral AS During surgery/procedure Determined after atherectomy and prior to other adjunctive therapies
Procedural Success Rate End of surgery/procedure Defined as the proportion of the target lesion in which the final stenosis is ≤30% after treatment with atherectomy and any other adjunctive therapy
Clinical Success Rate 30-day and 6-month follow-up Defined as the proportion of subjects who have procedural success in all target lesions with at least one grade of improvement in the Rutherford clinical classification
Incidence of angiographic procedural distal embolization in the target limb During surgery/procedure As reported by the angiographic core laboratory
Rates of all adverse events classified as MAEs 30-day and 6-month follow-up As adjudicated by the CEC and presented by seriousness and causality (procedure and device relatedness)
Incidence of minor target limb amputation 30-day and 6-month follow-up As adjudicated by the CEC
Incidence of target vessel revascularization (TVR) in the target limb 30-day and 6-month follow-up As adjudicated by the CEC
Time to secondary patency of the target lesion(s) 6 months Secondary patency is the interval from the time of the index procedure until the time total occlusion is confirmed in a target vessel, including interventions designed to reestablish patency in a total occluded vessel, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
Trial Locations
- Locations (12)
Advanced Heart and Vascular Institute
🇺🇸Flemington, New Jersey, United States
HonorHealth Scottsdale Osborn Medical Center
🇺🇸Scottsdale, Arizona, United States
Palm Vascular Center
🇺🇸Fort Lauderdale, Florida, United States
First Coast Cardiovascular Institute
🇺🇸Jacksonville, Florida, United States
Radiology and Imaging Specialists of Lakeland
🇺🇸Lakeland, Florida, United States
Amavita Research Services
🇺🇸Miami, Florida, United States
Cardiovascular Consultants of South Georgia
🇺🇸Thomasville, Georgia, United States
Baton Rouge General Hospital
🇺🇸Baton Rouge, Louisiana, United States
Cardiovascular Institute of the South - Houma
🇺🇸Houma, Louisiana, United States
Cardiovascular Institute of the South - Lafayette
🇺🇸Lafayette, Louisiana, United States
Vascular Breakthroughs
🇺🇸Plymouth, Massachusetts, United States
Hope Vascular & Podiatry
🇺🇸Houston, Texas, United States