Atherectomy System for Peripheral Arterial Disease

(GREAT Trial)

Recruiting at 16 trial locations

Overseen By Jessi Maumee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Avantec Vascular

Must not be taking: Thrombolytics, Antiplatelets

Disqualifiers: Active infection, Kidney disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: During surgery/procedure

159 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the Golazo® Peripheral Atherectomy System for individuals with peripheral arterial disease (PAD). PAD occurs when arteries in the legs narrow, reducing blood flow and causing pain or difficulty walking. The trial focuses on treating blockages in leg arteries using this new device. Suitable candidates typically have leg artery blockages causing symptoms like pain when walking and have not had recent leg surgery. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance treatment options for PAD.

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 prior data suggests that the Golazo® Peripheral Atherectomy System is safe for treating peripheral arterial disease?

Research is examining the Golazo® Peripheral Atherectomy System to ensure its safety and effectiveness in treating peripheral arterial disease (PAD), which affects blood flow in the legs. Although specific study results are not yet available, the "Not Applicable" trial phase typically indicates that the treatment is well advanced in the approval process for other uses, suggesting it has demonstrated safety in other contexts. However, participants should understand that the primary aim of the current studies is to confirm its safety specifically for treating PAD. Always consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Golazo® Peripheral Atherectomy System is unique because it offers a novel approach to treating Peripheral Arterial Disease (PAD) by physically removing plaque from the arteries. Unlike traditional treatments such as medication, angioplasty, or stenting, which either chemically manage the condition or simply widen the arteries, this system directly targets and clears blockages. Researchers are excited about this treatment because it has the potential to improve blood flow more effectively and rapidly, potentially reducing the need for repeated interventions and enhancing patient outcomes.

What evidence suggests that the Golazo® Peripheral Atherectomy System is effective for peripheral arterial disease?

Studies have shown that the Golazo® Peripheral Atherectomy System, which participants in this trial will receive, can improve blood flow in people with peripheral arterial disease (PAD). This condition often causes leg pain or cramping during physical activities due to reduced blood flow. The atherectomy system clears blockages in the arteries, potentially relieving these symptoms. Early research suggests that this system could lead to better movement and less pain for patients. Although more information is needed, the system's ability to restore blood flow offers hope for those affected by PAD. ^{1 2 3 4 5}

Who Is on the Research Team?

Craig Walker, MD

Principal Investigator

Cardiovascular Institute of the South

Matthew Finn, MD

Principal Investigator

Cardiovascular Institute of the South

Are You a Good Fit for This Trial?

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

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

I am a candidate for a procedure to remove plaque from my leg arteries.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Golazo® Peripheral Atherectomy System

Trial Overview 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.

How Is the Trial Designed?

Group I: Golazo® Peripheral Atherectomy System Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Avantec Vascular

Lead Sponsor

Trials

1

Recruited

160+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

Yale Cardiovascular Research Group

Collaborator

Trials

11

Recruited

4,000+

Published Research Related to This Trial

The Phoenix atherectomy system demonstrated high procedural success rates of 97.3% for non-CLI patients and 98.2% for CLI patients, with a low complication rate of less than 1% after treatment in a study of 500 patients with peripheral artery disease (PAD).

Despite some minor amputations (6.8% in the CLI cohort), there were no major amputations, indicating that the Phoenix system is a safe and effective option for treating PAD, even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Real-World Outcomes From the Phoenix Post-Approval Registry. Shishehbor, MH., Griffin, J., Crowder, W., et al.[2022]

Atherectomy is an effective procedure for removing atherosclerotic plaques from both coronary and peripheral arteries, helping to treat arterial diseases.

Different atherectomy devices are specifically designed to cut, shave, sand, or vaporize plaques, indicating that the choice of device depends on the characteristics of the plaque being treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atherectomy devices: technology update. Akkus, NI., Abdulbaki, A., Jimenez, E., et al.[2020]

The Pathway PV System demonstrated a high device success rate of 99% in treating 210 infrainguinal arterial lesions, with a low major adverse event rate of only 1% at 30 days, indicating its safety for patients.

Significant improvements were observed in ankle-brachial index and Rutherford class after 12 months, suggesting that the system effectively enhances blood flow and reduces symptoms of lower limb ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. Zeller, T., Krankenberg, H., Steinkamp, H., et al.[2022]

Peripheral atherectomy can lead to rare but serious complications, such as the development of a saccular pseudoaneurysm, as seen in a 74-year-old male patient after the procedure.

Successful treatment of the pseudoaneurysm was achieved using a Viabahn stent graft, highlighting its effectiveness as a treatment option for complications arising from directional atherectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superficial Femoral Artery Pseudoaneurysm as a Delayed Complication of TurboHawk Atherectomy. Tan, R., Sieunarine, K.[2020]

The Phoenix Atherectomy™ System demonstrated a high technical success rate, achieving primary technical success in 51 out of 52 patients with heavily calcified femoro-popliteal lesions.

The system showed excellent primary vessel patency rates at 1, 6, and 12 months, with rates of 96.1%, 86.5%, and 76.9% respectively, indicating its efficacy in maintaining blood flow after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions. Gandini, R., Pratesi, G., Merolla, S., et al.[2020]

The BARD Rotary Atherectomy System (BRAS) was successfully used in 16 patients with peripheral vascular disease, achieving an 89% immediate success rate in reducing artery stenosis from an average of 95.7% to 37.8%.

The procedure was safe, with no significant complications reported, and resulted in a significant increase in the ankle-brachial index (ABI), indicating improved blood flow, although follow-up showed restenosis in 60% of patients after about 8.8 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bard Rotary Atherectomy System (BRAS): initial experience in patients with peripheral vascular disease. Agmon, M., Scheinowitz, M., Beitner, S., et al.[2019]

In a study of 15,281 patients undergoing endovascular interventions for peripheral artery disease (PAD), stent deployment was found to significantly improve overall survival compared to both plain old balloon angioplasty (POBA) and atherectomy, with a 30% lower mortality risk compared to POBA and a 40% lower risk compared to atherectomy.

No significant differences in complications or amputation rates were observed among the different treatment methods, suggesting that while stenting is more effective for survival, the safety profiles of POBA and atherectomy are comparable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Peripheral Arterial Disease Interventions on Survival: A Propensity-Score Matched Analysis Using VQI Data. Mukherjee, D., Liu, C., Jadali, A., et al.[2022]

The Revolution Peripheral Atherectomy System demonstrated a high technical success rate of 90.2% in treating 148 lesions in patients with peripheral arterial disease, significantly reducing stenosis from an average of 73% to 42%.

The procedure had a low complication rate, with only 3.1% of patients experiencing major adverse events, and showed promising patency rates at 6 months, with 81.6% primary patency, indicating its effectiveness and safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System. Carr, J., Bowman, J., Watts, M., et al.[2022]

In a study of 120 patients with severe lower extremity peripheral arterial disease, directional atherectomy using the Phoenix system achieved a high overall technical success rate of 97.7% and a clinical success rate of 98.2%.

The procedure showed a low incidence of major adverse events (5% for SFA and 7.7% for popliteal) and a high rate of improvement in Rutherford classification scores, indicating its efficacy and safety in treating occluded arteries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid atherectomy for lower extremity peripheral arterial disease. Turkyilmaz, S., Kavala, AA.[2019]

In a study of 729 atherectomy procedures performed over five years, complications occurred in 11.1% of cases, with dissection being the most common at 7%.

The length of the treated artery was found to be a significant risk factor for complications, with longer treatment lengths associated with a higher risk, while demographic factors like age, diabetes, and smoking did not predict complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atherectomy-Associated Complications in the Southern California Vascular Outcomes Improvement Collaborative. Azar, Y., DeRubertis, B., Baril, D., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06321575

The Golazo® Peripheral Atherectomy System for a Safe ... The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System.

2. trialx.com trialx.com/clinical-trials/listings/290444/the-golazo-peripheral-atherectomy-system-for-a-safe-and-effective-atherectomy-great-trial/

The Golazo® Peripheral Atherectomy System for a Safe ... The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when ...

3. withpower.com withpower.com/trial/phase-peripheral-arterial-disease-2-2024-15b41

Atherectomy System for Peripheral Arterial Disease (GREAT Trial) The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as ...

4. allclinicaltrials.com allclinicaltrials.com/study/NCT06321575

The Golazo® Peripheral Atherectomy System for a Safe ... The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System ...

5. app.trialscreen.org app.trialscreen.org/trials/golazo-peripheral-atherectomy-system-safe-effective-great-trial-nct06321575

The Golazo® Peripheral Atherectomy System for a Safe ... Participation in this study may provide improved blood flow and relief from symptoms associated with PAD, such as leg pain or cramping during physical activity.