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

Trial Summary

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 data supports the effectiveness of the Pantheris SV catheter treatment for Peripheral Artery Disease?

The study on the Phoenix atherectomy catheter showed significant improvement in patients with peripheral artery disease, suggesting that similar atherectomy devices like the Pantheris SV catheter may also be effective. Additionally, the SilverHawk Plaque Excision System, another atherectomy device, demonstrated positive results in reducing the need for additional procedures and maintaining vessel openness over time. ^{1 2 3 4 5}

Is the Pantheris SV catheter safe for use in humans?

The Phoenix atherectomy system, similar to the Pantheris SV catheter, has been studied for safety in treating peripheral artery disease. In one study, only one minor bleeding complication was reported, suggesting it is generally safe for use in humans. ^{4 6 7 8 9}

How does the Pantheris SV catheter treatment for Peripheral Artery Disease differ from other treatments?

The Pantheris SV catheter is a type of atherectomy device that removes plaque from arteries, offering the advantage of reducing arterial wall injury and potentially lowering the risk of restenosis (re-narrowing of the artery) compared to traditional methods like angioplasty and stenting. Unlike other atherectomy devices, it is specifically designed for small vessels, which may make it more effective in treating peripheral artery disease in these areas. ^{1 3 5 10 11}

What is the purpose of this trial?

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 be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.

Research Team

Jaafer Golzar, MD

Principal Investigator

Avinger, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of Patterns of Atherectomy Use. [2022]

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

Evaluation of the pullback atherectomy catheter in the treatment of lower limb vascular disease. [2018]

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

Treatment of severe infrapopliteal vascular disease using a novel atherectomy device: a case report. [2016]

4. Switzerland 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. [2022]

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

Atherectomy for infrainguinal peripheral artery disease. [2009]

6. 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]

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

Effect of percutaneous coronary interventions for in-stent restenosis in degenerated saphenous vein grafts without distal embolic protection. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Initial clinical experience with a new percutaneous peripheral atherectomy device for the treatment of femoro-popliteal stenoses]. [2016]

9. United States 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. [2016]

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

Peripheral atherectomy: a critical review. [2014]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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