Atherectomy System for Peripheral Arterial Disease

(GREAT Trial)

Recruiting at 11 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

Trial Summary

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. ^{1 2 3 4 5}

Is 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). ^{2 4 6 7 8}

What 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. ^{1 3 4 9 10}

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.

Research Team

Craig Walker, MD

Principal Investigator

Cardiovascular Institute of the South

Matthew Finn, MD

Principal Investigator

Cardiovascular Institute of the South

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Bard Rotary Atherectomy System (BRAS): initial experience in patients with peripheral vascular disease. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Hybrid atherectomy for lower extremity peripheral arterial disease. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Peripheral Arterial Disease Interventions on Survival: A Propensity-Score Matched Analysis Using VQI Data. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Superficial Femoral Artery Pseudoaneurysm as a Delayed Complication of TurboHawk Atherectomy. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Atherectomy-Associated Complications in the Southern California Vascular Outcomes Improvement Collaborative. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Acute Real-World Outcomes From the Phoenix Post-Approval Registry. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Atherectomy devices: technology update. [2020]

10. United States 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. [2022]