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

Peripheral Arterial Disease Clinical Trial

— GREAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321575
• Other study ID #: AVA-CL-5000
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: November 2026

Study information

• Verified date: June 2024
• Source: Avantec Vascular
• Contact: Gene Reu
• Phone: 858-945-0007
• Email: GReu[@]avantecvascular.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 159
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

General inclusion 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. Either of the following objective hemodynamic criteria:

1. Resting ankle brachial index (ABI) =0.90, or =0.75 after exercise

2. Subjects with non-compressible arteries (ABI >1.1) with a toe brachial index (TBI) =0.80

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 =15 cm by angiographic visual estimation

11. Target reference vessel diameter =2.0 mm and =4.5 mm by angiographic visual estimation

12. At least one patent tibial vessel runoff at baseline

General exclusion criteria:

1. Active infection in the target limb

2. History of an endovascular procedure or open vascular surgery on the target limb, including proximal inflow vessels 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)

Angiographic exclusion criteria:

20. More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single lesion

21. Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device

22. In-stent restenosis within the target lesion(s)

23. Potentially unstable or flow-limiting dissection, type C or greater

24. Clinical/angiographic evidence of distal embolization

25. Target lesion containing severe calcification that is intra-luminal and is not imageable under angiography

26. Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
Golazo® Peripheral AS is a sterile, single-use percutaneous device that has two main components: 1) the Golazo® Accustrike atherectomy catheter, and 2) the Golazo® motorized drive unit (MDU) and is intended for use in atherectomy of the peripheral vasculature.

Locations

Country	Name	City	State
United States	Cardiovascular Institute of the South - Houma	Houma	Louisiana
United States	Radiology and Imaging Specialists of Lakeland	Lakeland	Florida
United States	Cardiovascular Consultants of South Georgia	Thomasville	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Avantec Vascular	Bright Research Partners, Yale Cardiovascular Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major adverse events (MAE)	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 intervention	Index procedure through 30-day follow-up
Primary	Technical success	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	During surgery/procedure
Secondary	Change in % stenosis in target lesion after treatment with Golazo Peripheral AS	Determined after atherectomy and prior to other adjunctive therapies	During surgery/procedure
Secondary	Procedural Success Rate	Defined as the proportion of the target lesion in which the final stenosis is =30% after treatment with atherectomy and any other adjunctive therapy	End of surgery/procedure
Secondary	Clinical Success Rate	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	30-day and 6-month follow-up
Secondary	Rates of all adverse events classified as MAEs	As adjudicated by the CEC and presented by seriousness and causality (procedure and device relatedness)	30-day and 6-month follow-up
Secondary	Incidence of minor target limb amputation		30-day and 6-month follow-up
Secondary	Incidence of myocardial infarction		30-day and 6-month follow-up
Secondary	Incidence of target vessel revascularization (TVR) in the target limb		30-day and 6-month follow-up
Secondary	Incidence of angiographic procedural distal embolization in the target limb		During surgery/procedure
Secondary	Time to primary patency of the target vessels	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.	6 months
Secondary	Time to assisted primary patency of the target vessels	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.	6 months
Secondary	Time to secondary patency of the target vessels	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.	6 months