Atherectomy for Peripheral Artery Disease

Recruiting at 1 trial location

Overseen By Ruth Lira, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Avinger, Inc.

Disqualifiers: Pregnancy, Recent surgery, Major bleeding, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Pantheris SV catheter, for treating peripheral artery disease in the legs, specifically below the knee. The researchers aim to determine how effectively this device clears blockages and improves symptoms over time. Ideal participants have a blockage in the lower leg and have experienced related issues like pain or sores. Researchers will check participants at 30 days, 6 months, and 1 year after the procedure to monitor progress and any side effects. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance treatment options for peripheral artery disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Pantheris SV catheter is safe for addressing peripheral artery disease?

Research has shown that the Pantheris SV catheter is a safe tool for treating peripheral artery disease. The FDA has approved it for use, confirming it meets safety standards for medical devices. In a related study, the Pantheris SV catheter effectively treated small blood vessels, indicating it is likely well-tolerated by patients.

Although a detailed list of specific side effects is unavailable, its approval and use in other studies suggest that serious side effects are rare. Participants in a trial using this device will undergo regular monitoring by researchers for any symptoms or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Pantheris SV catheter is unique because it offers a new approach to treating Peripheral Artery Disease (PAD) by combining imaging and treatment in one device. Unlike traditional options like angioplasty or stenting, which can sometimes be less effective in removing plaque, the Pantheris SV catheter uses advanced imaging technology to precisely target and remove plaque from the arteries. This precision not only enhances the effectiveness of the treatment but also minimizes damage to the artery, potentially leading to quicker recovery times. Researchers are excited about this innovation because it could significantly improve outcomes for patients with PAD, offering a more efficient and safer alternative to existing treatments.

What evidence suggests that the Pantheris SV catheter is effective for peripheral artery disease?

Research shows that atherectomy, a procedure to clear plaque from blood vessels, may help treat peripheral artery disease (PAD) in the legs. This trial will evaluate the Pantheris SV catheter, designed for use in small blood vessels below the knee. Studies with similar devices have greatly improved blood flow and reduced blockages. The Pantheris SV uses advanced imaging to guide the procedure, potentially enhancing accuracy and results. Although specific data on the Pantheris SV catheter is still being gathered, its design suggests it could effectively reduce artery narrowing and improve symptoms in PAD patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Jaafer Golzar, MD

Principal Investigator

Avinger, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with Peripheral Arterial Disease affecting arteries below the knee, who have at least one blood vessel visible in the foot and are experiencing moderate to severe symptoms. Pregnant or breastfeeding women, recent surgery patients, those with major bleeding events, or individuals involved in other drug/device trials cannot participate.

Inclusion Criteria

I have at least one blood vessel visible in my foot.

My target lesion is below the knee.

My leg pain is severe, affecting my daily activities.

Exclusion Criteria

I am scheduled for surgery within 30 days after my initial procedure.

I am not pregnant or breastfeeding.

I had surgery or a procedure involving blood vessels within the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo directional atherectomy using the Pantheris SV catheter, followed by adjunctive therapy as necessary

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and symptom resolution

1 year

3 visits (in-person) at 30 days, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Pantheris SV catheter

Trial Overview The study is testing the Pantheris SV catheter's effectiveness in treating artery blockages below the knee. Participants will undergo atherectomy and be monitored for changes in artery narrowing before and after treatment as well as any symptoms or complications up to one year post-procedure.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Single-arm study

Pantheris SV catheter is already approved in United States, European Union for the following indications:

Approved in United States as Pantheris SV for:

• Peripheral artery disease in small vessels (2mm–4mm in diameter)

Approved in European Union as Pantheris SV for:

• Peripheral artery disease in small vessels (2mm–4mm in diameter)

Who Is Running the Clinical Trial?

Avinger, Inc.

Lead Sponsor

Trials

8

Recruited

550+

Published Research Related to This Trial

The Pullback Atherectomy Catheter (PAC) demonstrated a high technical success rate of 97.4% in treating lower limb vascular disease in 34 patients, significantly reducing arterial stenosis from 89.4% to 12.1%.

Despite its effectiveness, 69.2% of procedures required additional balloon dilatation to achieve satisfactory results, and complications occurred in 15.4% of cases, indicating that while PAC is relatively safe, it may not be sufficient on its own for optimal arterial lumen restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the pullback atherectomy catheter in the treatment of lower limb vascular disease. Grubnic, S., Heenan, SD., Buckenham, TM., et al.[2018]

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 2019, a study of 59 providers performing 4060 atherectomy procedures revealed that a small number of providers conducted the majority of these procedures and received significantly higher reimbursements per procedure, with median reimbursements of $4671.56 from Blue Cross Blue Shield and $14,854.49 from Medicare.

The study found that the rate at which providers converted new patient visits to endovascular procedures was correlated with total annual reimbursement, suggesting that monitoring these conversion rates and treatment patterns could help address the overuse of atherectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Patterns of Atherectomy Use. Brown, CS., Eton, RE., Yaser, JM., et al.[2022]

Atherectomy is gaining popularity among specialists for treating peripheral artery disease due to its potential advantages over traditional methods like angioplasty and stenting, particularly in areas with high restenosis rates.

While devices like the SilverHawk atherectomy show promising short-term results, there is a critical need for more long-term data (12 months or more) to establish their efficacy and safety for broader acceptance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral atherectomy: a critical review. Bunting, TA., Garcia, LA.[2014]

In a study of 54 patients with in-stent restenosis in degenerated saphenous vein grafts, PCI was performed without distal embolic protection, resulting in a high procedural success rate of 98% and no incidents of no reflow or slow flow during the procedures.

The findings suggest that distal embolic protection may not be necessary for PCI of in-stent restenosis lesions in degenerated SVGs, as there were no procedure-related myocardial infarctions or significant complications during the hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of percutaneous coronary interventions for in-stent restenosis in degenerated saphenous vein grafts without distal embolic protection. Ashby, DT., Dangas, G., Aymong, EA., et al.[2019]

The SilverHawk Plaque Excision System has shown promising results in treating femoropopliteal and infrainguinal lesions, achieving an 80% freedom from target lesion revascularization at 12 months in the TALON registry with minimal need for adjunctive procedures.

While atherectomy theoretically reduces arterial wall injury and restenosis rates compared to traditional methods, historical data indicates that it has not consistently demonstrated long-term benefits over conventional PTA alone, highlighting the need for further research on its efficacy and optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atherectomy for infrainguinal peripheral artery disease. Garcia, LA., Lyden, SP.[2009]

The use of the 1.5 mm Phoenix atherectomy catheter for below-the-knee atherectomy in patients with infragenicular peripheral arterial disease (PAD) showed significant improvement in ankle-brachial indices (ABI) after 2 weeks and 6 months, indicating enhanced blood flow.

The study reported a decrease in severe PAD cases (stage IV) by 15.2% and an improvement to a less severe stage (stage IIa) in 18.2% of patients, with only one minor bleeding complication noted, suggesting the procedure is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Feasibility and Patency of below the Knee Atherectomy Using the 1.5 mm Phoenix Catheter-A Retrospective Study. Kumarasamy, A., Gombert, A., Krabbe, J., et al.[2022]

This study presents the first two human cases of using a new device called the PV atherectomy for treating severe blockages in the popliteal artery, which is crucial for blood flow in the leg.

The use of this novel percutaneous revascularization technique shows promise for improving blood circulation in patients with significant arterial disease, although further studies are needed to assess its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of severe infrapopliteal vascular disease using a novel atherectomy device: a case report. Caputo, RP., Ebner, A., Garcia, L.[2016]

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]

Excimer laser atherectomy is a feasible treatment for degenerated saphenous vein graft lesions, showing a 30-day major adverse cardiac event (MACE) rate of 18.4% in a study of 98 patients across 18 centers, which is comparable to results from the SAFER trial.

The study identified several predictors of MACE, including lesion length and plaque burden, suggesting that careful patient selection and assessment of these factors may improve outcomes in future procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective multicenter registry of laser therapy for degenerated saphenous vein graft stenosis: the COronary graft Results following Atherectomy with Laser (CORAL) trial. Giugliano, GR., Falcone, MW., Mego, D., et al.[2016]

The new 7F-atherectomy device effectively treated 58 femoropopliteal stenoses in 46 patients, achieving a significant reduction in stenosis from an average of 83% to 11% after treatment, with 95% of lesions having less than 50% residual stenosis.

The procedure had a low complication rate, with only 6.5% of cases experiencing embolism, which was successfully managed, indicating the device's safety and efficacy for treating arterial lesions up to 8 cm in length.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Initial clinical experience with a new percutaneous peripheral atherectomy device for the treatment of femoro-popliteal stenoses]. Zeller, T., Krankenberg, H., Reimers, B., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04793581

Assessment of the Utility of the Pantheris Small Vessel (SV) ... A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will ...

2. trialx.com trialx.com/clinical-trials/listings/271000/assessment-of-the-utility-of-the-pantheris-small-vessel-sv-system/

Assessment of the Utility of the Pantheris Small Vessel (SV) ... A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee ...

3. withpower.com withpower.com/trial/phase-peripheral-arterial-disease-2021-8f657

Atherectomy for Peripheral Artery Disease The study on the Phoenix atherectomy catheter showed significant improvement in patients with peripheral artery disease, suggesting that similar atherectomy ...

4. biospace.com biospace.com/press-releases/avinger-releases-updated-data-from-image-btk-in-webinar-featuring-key-opinion-leaders-in-the-field-of-vascular-intervention

Avinger Releases Updated Data From IMAGE-BTK in ... Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of ...

5. firstwordhealthtech.com firstwordhealthtech.com/story/4937035

Avinger Enrolls First Patient in IMAGE-BTK Clinical Study ... IMAGE-BTK is a post-market trial designed to evaluate safety and efficacy endpoints for Pantheris SV in the treatment of peripheral artery lesions below-the- ...

6. sec.gov sec.gov/Archives/edgar/data/1506928/000143774919006832/ex_140277.htm

Avinger Receives FDA Clearance of Pantheris SV Device Pantheris SV uses a combination of directional atherectomy with onboard image-guidance to provide several potential clinical advantages, ...