Boomerang Catheter for Critical Limb Ischemia

Enrolling by invitation at 19 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called the Boomerang Catheter for individuals with severe leg artery blockages, known as Chronic Limb-Threatening Ischemia (CLTI). The catheter improves blood flow in the legs when other surgical options are unavailable. It suits adults who have been advised that no other surgical options exist and who experience severe blood flow issues in their legs. Participants should also belong to a wound care network and have stable wounds.

As an unphased trial, this study provides patients a unique opportunity to explore innovative treatment options when conventional surgeries are not viable.

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 prior data suggests that the Boomerang Catheter is safe for percutaneous Deep Venous Arterialization?

Research has shown that the Boomerang Catheter demonstrates promising safety results from earlier studies. A review of similar procedures, such as percutaneous Deep Venous Arterialization (pDVA), found a high success rate of 96.2% and a survival rate of 82.8%, indicating that the procedure is generally well-tolerated. Although specific data on side effects for the Boomerang Catheter itself is lacking, the high success and survival rates provide some reassurance about its safety for treating chronic limb-threatening ischemia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Boomerang Catheter is unique because it offers a minimally invasive approach to treating critical limb ischemia, a condition that often relies on more invasive surgeries or long-term medication management. Unlike traditional methods like bypass surgery or angioplasty, the Boomerang Catheter is designed to precisely target and open blocked arteries in the limbs, potentially improving blood flow more directly and with fewer complications. Researchers are excited about this treatment because it could reduce recovery times and hospital stays, making it a promising option for patients who are at high risk for surgical procedures.

What evidence suggests that the Boomerang Catheter is effective for treating Chronic Limb-Threatening Ischemia?

Research shows that the Boomerang Catheter, which participants in this trial will receive, holds promise for treating severe blood flow problems in the limbs. It has improved blood circulation in complex procedures. A study that combined results from different trials found a high success rate of 96.2% with similar treatments, and an overall survival rate of 82.8%. These findings suggest it could effectively restore blood flow to limbs when other treatments have failed. The catheter redirects blood flow to enhance circulation in the affected limb. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

withpower.com

withpower.com/trial/phase-ischemia-3-2024-2eb70

Boomerang Catheter 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 ...

2.

jcto.weill.cornell.edu

jcto.weill.cornell.edu/open_clinical_trials/boomerang-pivotal-multicenter-trial-of-the-boomerang-catheter-for-percutaneous-deep-vein-arterialization-pdva

Boomerang-Pivotal Multicenter Trial of the ...

The purpose of the trial is to find out if an investigational device called the “Boomerang Catheter System,” containing Boomerang Catheter and Boomerang Power ...

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ctv.veeva.com

ctv.veeva.com/study/pivotal-trial-of-the-boomerang-catheter-for-pdva

Pivotal Trial of the Boomerang Catheter for pDVA

The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA)

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10886738/

Short-Term Outcomes and Efficacy of Percutaneous Deep ...

The meta-analysis reached a pooled technical success rate of 96.2% (95% CI: 91.5–98.4), an overall survival of 82.8% (95% CI: 70.5–95.2) and a ...

5.

rush.edu

rush.edu/clinical-trials/boomerang-stentless-deep-vein-arterialization-preventing-major-amputation

Boomerang Stentless Deep Vein Arterialization for ...

Study evaluating efficacy of using a novel stentless device for Deep Vein Arterialization (TADV) procedures for patients with Chronic Limb Threatening Ischemia

6.

clinconnect.io

clinconnect.io/trials/NCT06311773

Pivotal Trial of the Boomerang Catheter for pDVA - ClinConnect

The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38397920/

Short-Term Outcomes and Efficacy of Percutaneous Deep ...

The meta-analysis reached a pooled technical success rate of 96.2% (95% CI: 91.5-98.4), an overall survival of 82.8% (95% CI: 70.5-95.2) and a ...

8.

mdpi.com

mdpi.com/2227-9059/12/2/318

Short-Term Outcomes and Efficacy of Percutaneous Deep ...

The meta-analysis reached a pooled technical success rate of 96.2% (95% CI: 91.5–98.4), an overall survival of 82.8% (95% CI: 70.5–95.2) and a ...