The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
Purpose
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.
Condition
- Peripheral Arterial Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥18 years 2. Candidate for atherectomy of the peripheral vasculature in the lower limbs 3. Life expectancy >1 year in the opinion of the investigator 4. 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. 5. Target limb Rutherford clinical classification category 3 to 5 6. Suitable candidate for angiography and endovascular intervention in the opinion of the investigator 7. Willing and able to comply with the protocol-specified procedures and assessments 8. Informed consent granted Angiographic inclusion criteria: 9. Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation 10. Total treated lesion length ≤20 cm by angiographic visual estimation 11. Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation 12. 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
Exclusion Criteria
- Active infection in the target limb 2. History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days 3. Planned surgical or interventional procedure within 30 days after the index procedure 4. Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days 5. Critical limb ischemia (CLI) with Rutherford clinical classification category 6 6. Significant acute or chronic kidney disease with a GFR <30 and/or requiring dialysis 7. Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator 8. Myocardial infarction (MI) or stroke within two months of baseline evaluation 9. Pregnant or lactating 10. 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 registries are allowed as long as the investigator determines there is no clinical interference with study endpoints) 11. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy 12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count <125,000/microliter, known coagulopathy, or international normalized ratio (INR) >1.5 13. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated 14. History of heparin-induced thrombocytopenia (HIT) 15. Any thrombolytic therapy within two weeks of enrollment 16. Target lesion(s) within a native vessel graft or synthetic graft 17. Significant stenosis or occlusion of inflow not successfully treated before the index procedure 18. Any evidence or history of intracranial or gastrointestinal bleeding or intracranial aneurysm 19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 20. One or more of the following complications of the foot: 1. Osteomyelitis that extends to the metatarsal bones. 2. Gangrene involving the plantar skin of the forefoot, midfoot or heel 3. Deep ulcer or large shallow ulcer (>3cm) involving the plantar skin of the forefoot, midfoot, or heel 4. Any heel ulcer with/without calcaneal involvement 5. Any wound with calcaneal bone involvement 6. Wounds that are deemed to be neuropathic or non-ischemic in nature 7. Wounds that require flap coverage or complete wound management for large soft tissue defect 21. Congestive heart failure with a NYHA functional classification of III or higher Angiographic exclusion criteria: 22. More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single tandem lesion 23. Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device 24. In-stent restenosis within the target lesion(s) 25. Potentially unstable or flow-limiting dissection, type C or greater 26. Clinical/angiographic evidence of distal embolization 27. Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Golazo® Peripheral Atherectomy System |
Treatment atherectomy of the peripheral vasculature with the Golazo® Peripheral Atherectomy System. |
|
Recruiting Locations
Pulse Cardiovascular Institute
Scottsdale, Arizona 85251
Scottsdale, Arizona 85251
Contact:
Anita Ramaiah, MD
480-600-0600
Anita Ramaiah, MD
480-600-0600
Merced Vascular
Merced, California 95340
Merced, California 95340
Palm Vascular Center
Fort Lauderdale, Florida 33312
Fort Lauderdale, Florida 33312
First Coast Cardiovascular Institute
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Amavita Research Services
Miami, Florida 33137
Miami, Florida 33137
Pacific Vascular Institute
‘Aiea, Hawaii 96701
‘Aiea, Hawaii 96701
Baton Rouge General Hospital
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Contact:
Jamie Mooney
225-237-1673
Jamie Mooney
225-237-1673
Cardiovascular Institute of the South - Houma
Houma, Louisiana 70360
Houma, Louisiana 70360
Cardiovascular Institute of the South - Lafayette
Lafayette, Louisiana 70506
Lafayette, Louisiana 70506
Vascular Breakthroughs
Plymouth, Massachusetts 02360
Plymouth, Massachusetts 02360
Contact:
Elizabeth Gagne
203-548-7860
Elizabeth Gagne
203-548-7860
Advanced Heart and Vascular Institute
Flemington, New Jersey 08822
Flemington, New Jersey 08822
Contact:
Alexis Bellafiore
908-237-3405
Alexis Bellafiore
908-237-3405
Spartanburg Regional Medical Center
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Tennessee Center for Clinical Trials
Tullahoma, Tennessee 37388
Tullahoma, Tennessee 37388
Nextstage Clinical Research - Beaumont
Beaumont, Texas 77702
Beaumont, Texas 77702
Nextstage Clinical Research - Waco
Waco, Texas 76712
Waco, Texas 76712
Bellin Health
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Contact:
Katherine Guilliams
920-617-2060
Katherine Guilliams
920-617-2060
More Details
- Status
- Recruiting
- Sponsor
- Avantec Vascular
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.