Boomerang Catheter for Critical Limb Ischemia

Recruiting at 12 trial locations

Overseen By Chris Chapek

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aveera Medical, Inc.

Must not be taking: Anticoagulants, ADP antagonists

Disqualifiers: Dialysis, Kidney disease, Stroke, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate to 6 months

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have a known contraindication (reason not to use) to aspirin, certain blood thinners, or anticoagulants. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the Boomerang Catheter treatment for Critical Limb Ischemia?

The Boomerang Catheter has been used successfully in complex procedures for critical limb ischemia, helping manage difficult arterial access issues and contributing to procedural success. Additionally, it has been shown to facilitate safe and effective vascular closure in other cardiovascular procedures, suggesting its potential usefulness in similar contexts. ^{1 2 3 4 5}

Is the Boomerang Catheter safe for use in humans?

The available research on cell therapy for critical limb ischemia, which may include treatments like the Boomerang Catheter, suggests a favorable safety profile with a low rate of adverse events and no increase in severe events such as mortality or cancer. ^{6 7 8 9 10}

How is the Boomerang Catheter treatment different from other treatments for critical limb ischemia?

The Boomerang Catheter is unique because it is used as a vascular closure device that facilitates complex revascularization procedures by managing arterial access issues without leaving any foreign body behind, which is crucial for patients with critical limb ischemia. ^{1 2 3 4 11}

Eligibility Criteria

This trial is for adults aged 18-85 with Critical Limb-Threatening Ischemia who can't be helped by standard treatments. They must have a clear vein suitable for the procedure, controlled diabetes if applicable, and agree to potential minor amputation. Those with significant artery blockage or conditions that rule out this treatment are excluded.

Inclusion Criteria

My imaging shows clear main leg arteries from my lower abdomen to my lower legs.

I am scheduled for a minor foot amputation within 30 days after my initial procedure.

I am willing and able to sign a consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA)

Immediate to 6 months

1 visit (in-person) for the index procedure

Follow-up

Participants are monitored for safety and effectiveness, including wound healing and limb salvage

3 years

Regular visits at 1, 3, 6, 9 months, 1 year, and 3 years

Treatment Details

Interventions

• Boomerang Catheter

Trial Overview The Boomerang Catheter's safety and effectiveness in creating new pathways for blood flow (pDVA) in patients with severe limb ischemia are being tested. The goal is to see if it can treat limbs when other options aren't available.

Participant Groups

Group I: Treated with Boomerang Catheter Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Aveera Medical, Inc.

Lead Sponsor

Trials

1

Recruited

120+

Findings from Research

In a study of 238 procedures for treating acute limb ischemia, both intra-arterial thrombolysis and thromboembolectomy showed similar primary patency and limb salvage rates, indicating that both methods are effective options.

However, the treatments were associated with a significant number of adverse events (AEs), with some leading to serious complications such as irreversible damage and death, highlighting the risks involved in these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after treatment of patients with acute limb ischemia. van der Slegt, J., Flu, HC., Veen, EJ., et al.[2015]

Vorapaxar significantly reduced major adverse cardiovascular events (MACE) by 15% and major adverse limb events (MALE) by 30% in patients with peripheral artery disease (PAD), based on an analysis of 6,136 patients from the TRA 2°P-TIMI 50 trial.

The effectiveness of vorapaxar varied among subgroups: it provided greater benefits in reducing MACE for patients with concomitant coronary artery disease (CAD) and greater benefits in reducing MALE for those with prior lower extremity revascularization, while also increasing the risk of major bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease: Analysis from the TRA 2°P-TIMI 50 trial. Qamar, A., Morrow, DA., Creager, MA., et al.[2020]

References

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

Use of the Boomerang catalyst advantage closure device to facilitate complex multistaged percutaneous revascularization procedures for the treatment of critical limb ischemia. [2022]

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

A comparison of the boomerang wire vascular access management system versus manual compression alone during percutaneous diagnostic and interventional cardiovascular procedures. [2017]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Short-Term Safety and Efficacy of Femoral Vascular Closure after Percutaneous Coronary Intervention with Combination of the Boomerang(TM) Device and Intravenous Protamine Sulfate. [2020]

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

Experience with the Cardiva Boomerang Catalyst system in pediatric cardiac catheterization. [2012]

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

Performance of BeBack Crossing Catheter in Chronic Total Occlusion in Patients With Chronic Limb-Threatening Ischemia: A Single-Center Experience. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Administration of Adult Human Bone Marrow-Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Critical Limb Ischemia Due to Buerger's Disease: Phase II Study Report Suggests Clinical Efficacy. [2019]

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

Safety and efficacy of autologous cell therapy in critical limb ischemia: a systematic review. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events after treatment of patients with acute limb ischemia. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease: Analysis from the TRA 2°P-TIMI 50 trial. [2020]

10. France pubmed.ncbi.nlm.nih.gov

[Treatment perspectives for critical limb ischemia: gene and cell therapy]. [2016]

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

Successful endovascular treatment in patients with acute thromboembolic ischemia of the lower limb including the crural arteries. [2020]