Atherectomy System for Peripheral Arterial Disease
(GREAT Trial)
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Avantec Vascular
Must not be taking: Thrombolytics, Antiplatelets
Disqualifiers: Active infection, Kidney disease, Heart failure, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you should not have a contraindication to antiplatelet, anticoagulant, or thrombolytic therapy, and you should not have had any thrombolytic therapy within two weeks of enrollment.
What data supports the effectiveness of the Golazo Peripheral Atherectomy System treatment for Peripheral Arterial Disease?
The Bard Rotary Atherectomy System (BRAS) study showed that a similar atherectomy system was able to successfully reduce artery blockages in 89% of cases, suggesting that mechanical atherectomy systems can be effective in treating peripheral arterial disease.
12345Is the Golazo Peripheral Atherectomy System safe for humans?
Atherectomy systems, like the Golazo Peripheral Atherectomy System, have been associated with risks such as embolization (blockage caused by a clot or debris), arterial perforation (a tear in the artery), and other complications like access site injury and hemorrhage (bleeding).
24678What makes the Golazo Peripheral Atherectomy System unique for treating peripheral arterial disease?
The Golazo Peripheral Atherectomy System is unique because it is a mechanical device specifically designed to remove plaque from arteries, potentially offering a more targeted approach compared to other treatments. Unlike some other atherectomy systems, it may incorporate features like rotational or directional mechanisms to effectively clear blockages in peripheral arteries.
134910Eligibility Criteria
This trial is for adults over 18 with symptomatic peripheral arterial disease affecting the legs. Participants must have a specific range of artery narrowing and be able to undergo an atherectomy, which is a procedure to remove plaque from arteries. They should not have had previous treatments that would affect the study's outcome.Inclusion Criteria
Life expectancy >1 year in the opinion of the investigator
I am 18 years old or older.
Either of the following objective hemodynamic criteria: Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise; Subjects with non-compressible arteries (ABI >1.1) with a toe brachial index (TBI) ≤0.80; Target limb Rutherford clinical classification category 3 to 5; Suitable candidate for angiography and endovascular intervention in the opinion of the investigator; Willing and able to comply with the protocol-specified procedures and assessments; Informed consent granted
+2 more
Exclusion Criteria
History of heparin-induced thrombocytopenia (HIT)
I have not had a recent heart attack or any uncontrolled health issues.
My condition is severe leg pain at rest due to poor blood flow, classified as the most severe.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Subjects undergo atherectomy treatment with the Golazo® Peripheral Atherectomy System
During surgery/procedure
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Multiple visits (in-person) at 30-day and 6-month intervals
Participant Groups
The Golazo® Peripheral Atherectomy System is being tested in patients with narrowed leg arteries due to plaque buildup. The goal is to see if this system can safely and effectively clear these blockages in up to 159 subjects across multiple U.S. sites.
1Treatment groups
Experimental Treatment
Group I: Golazo® Peripheral Atherectomy SystemExperimental Treatment1 Intervention
Treatment atherectomy of the peripheral vasculature with the Golazo® Peripheral Atherectomy System.
Golazo® Peripheral Atherectomy System is already approved in United States for the following indications:
🇺🇸 Approved in United States as Golazo Peripheral Atherectomy System for:
- Symptomatic infrainguinal peripheral arterial disease (PAD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cardiovascular Consultants of South GeorgiaThomasville, GA
Palm Vascular CenterFort Lauderdale, FL
Cardiovascular Institute of the South - LafayetteLafayette, LA
Vascular BreakthroughsPlymouth, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Avantec VascularLead Sponsor
Bright Research PartnersIndustry Sponsor
Yale Cardiovascular Research GroupCollaborator
References
The Bard Rotary Atherectomy System (BRAS): initial experience in patients with peripheral vascular disease. [2019]Sixteen patients with a mean age of 65.4 +/- 9.8 years and suffering from peripheral vascular disease underwent peripheral atherectomy using a new mechanical device--the BARD Rotary Atherectomy System (BRAS). The BRAS is an "over the wire" system that consists of a spiral guidewire and a handheld motor drive unit, which rotates at 1,500 rpm. Prior to the procedure angiography demonstrated the presence of 18 obstructions (1 tibial, 2 popliteal, 15 superficial femoral arteries) with a mean stenosis of 95.7 +/- 8%. Successful atherectomy was achieved in 16 of 18 lesions and resulted in an 89% immediate success rate and a significant (P less than 0.01) reduction of stenosis to 37.8 +/- 12.5%. There were no significant complications. The excised and removed material embedded over the spiral guidewire demonstrated the presence of fibrotic tissue, fatty lesions, and calcium deposits. Medial or adventitial layers were not present in the removed atherosclerotic material. Mean ABI was significantly (P less than 0.01) increased from 0.38 +/- 0.17 to 0.55 +/- 0.21 following atherectomy. Angiographic follow-up obtained in ten patients 8.8 +/- 5.2 months following the procedure demonstrated restenosis in six of those ten patients. The ABI at this time remained unchanged. These results demonstrated that the new BRAS mechanical atherectomy system is feasible and safe for recanalization of severely stenosed arteries in patients with peripheral vascular disease.
United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System. [2022]Atherectomy has become commonplace as an adjunct to interventional treatments for peripheral arterial disease, but the procedures have been complicated by risks including distal embolization and arterial perforation. This study aimed to examine the safety and effectiveness of a novel atherectomy system to treat femoropopliteal and below-knee peripheral arterial disease.
Hybrid atherectomy for lower extremity peripheral arterial disease. [2019]To evaluate the effectiveness of directional atherectomy with a Phoenix atherectomy system in lower extremity peripheral arterial disease (LE-PAD).
A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions. [2020]To evaluate efficacy and safety of a new rotational atherectomy (RA), the Phoenix Atherectomy™ System, for the treatment of de novo and re-stenotic or occlusions atherosclerotic moderate-heavily lesions of the femoro-popliteal axis.
Effects of Peripheral Arterial Disease Interventions on Survival: A Propensity-Score Matched Analysis Using VQI Data. [2022]Atherectomy is currently being used extensively for occlusive peripheral artery disease (PAD) interventions without proven benefits. This analysis examines the effects of atherectomy and other endovascular interventions on patient survival.
Superficial Femoral Artery Pseudoaneurysm as a Delayed Complication of TurboHawk Atherectomy. [2020]Peripheral atherectomy is utilized in the treatment of heavily calcified plaques from peripheral arterial lesions. Commonly reported complications include access site injury, perforations, dissections, embolism, and retroperitoneal hemorrhage.
Atherectomy-Associated Complications in the Southern California Vascular Outcomes Improvement Collaborative. [2019]Atherectomy has become an increasingly utilized modality for the endovascular treatment of peripheral arterial occlusive disease. The objective of this study was to determine the incidence and risk factors for atherectomy-associated complications.
Acute Real-World Outcomes From the Phoenix Post-Approval Registry. [2022]An evaluation of the 30-day safety and performance outcomes of the Phoenix atherectomy system (Philips Volcano Corporation) was performed in real-world patients with peripheral artery disease (PAD).
Atherectomy devices: technology update. [2020]Atherectomy is a procedure which is performed to remove atherosclerotic plaque from diseased arteries. Atherosclerotic plaques are localized in either coronary or peripheral arterial vasculature and may have different characteristics depending on the texture of the plaque. Atherectomy has been used effectively in treatment of both coronary and peripheral arterial disease. Atherectomy devices are designed differently to either cut, shave, sand, or vaporize these plaques and have different indications. In this article, current atherectomy devices are reviewed.
One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. [2022]To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions.