RECRUITING

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

Conditions

Peripheral Arterial Disease Symptomatic Infrainguinal Peripheral Arterial Disease Endovascular Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy

Quick Facts

Study Start:2024-06-20

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06321575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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	1. 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

Inclusion Criteria

Exclusion Criteria

1. 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

1. 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

Contacts and Locations

Study Contact

Gene Reu

CONTACT

858-945-0007

GReu@avantecvascular.com

Jessi Maumee

CONTACT

612-345-4544

jessi.maumee@brightresearch.com

Principal Investigator

Matthew Finn, MD

PRINCIPAL_INVESTIGATOR

Cardiovascular Institute of the South

Craig Walker, MD

PRINCIPAL_INVESTIGATOR

Cardiovascular Institute of the South

Study Locations (Sites)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251

United States

Pulse Cardiovascular Institute

Scottsdale, Arizona, 85251

United States

Palm Vascular Center

Fort Lauderdale, Florida, 33312

United States

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256

United States

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, 33801

United States

Amavita Research Services

Miami, Florida, 33137

United States

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, 31792

United States

Baton Rouge General Hospital

Baton Rouge, Louisiana, 70809

United States

Cardiovascular Institute of the South - Houma

Houma, Louisiana, 70360

United States

Cardiovascular Institute of the South - Lafayette

Lafayette, Louisiana, 70506

United States

Vascular Breakthroughs

Plymouth, Massachusetts, 02360

United States

Advanced Heart and Vascular Institute

Flemington, New Jersey, 08822

United States

Hope Vascular & Podiatry

Houston, Texas, 77054

United States

Bellin Health

Green Bay, Wisconsin, 54301

United States

Collaborators and Investigators

Sponsor: Avantec Vascular

Matthew Finn, MD, PRINCIPAL_INVESTIGATOR, Cardiovascular Institute of the South
Craig Walker, MD, PRINCIPAL_INVESTIGATOR, Cardiovascular Institute of the South

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-20

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-06-20

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

Symptomatic Infrainguinal Peripheral Arterial Disease
Endovascular Intervention

Additional Relevant MeSH Terms

Peripheral Arterial Disease