Peripheral Arterial Disease
Conditions
Keywords
Symptomatic Infrainguinal Peripheral Arterial Disease, Endovascular Intervention
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 20 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.
Interventions
DEVICEGolazo® 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.
Sponsors
Nipro Vascular Innovations Americas, Inc
Bright Research, Inc.
Yale Cardiovascular Research Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. 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
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 Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 intervention |
| Technical 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 myocardial infarction | 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 |
| Incidence of angiographic procedural distal embolization in the target limb | During surgery/procedure | As reported by the angiographic core laboratory |
| 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 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. |
| 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 |
Countries
United States
Contacts
CONTACTGene Reu
CONTACTJessi Maumee
PRINCIPAL_INVESTIGATORMatthew Finn, MD
Cardiovascular Institute of the South
PRINCIPAL_INVESTIGATORCraig Walker, MD
Cardiovascular Institute of the South
Outcome results
None listed