Esprit BTK Device for Critical Limb Ischemia

(LIFE-BTK Trial)

Recruiting at 60 trial locations

Overseen By Rhonda Hensley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Stroke, Renal insufficiency, Dialysis, Immunosuppressive disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

261 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed infrapopliteal lesions. Approximately 225 subjects will be randomized in a 2:1 ratio. The clinical investigation will be conducted at approximately 65 clinical sites in the US, Asia, Australia, and New Zealand.

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, if you have allergies or contraindications to certain drugs like aspirin or anticoagulants, you may not be eligible. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the Esprit BTK Device treatment for critical limb ischemia?

Research shows that endovascular treatments like angioplasty and stenting, which are part of the Esprit BTK Device treatment, have been effective in improving blood flow in below-the-knee arteries for patients with critical limb ischemia. Studies indicate that these treatments can lead to high rates of limb salvage and patency (keeping the blood vessel open) over time. ^{1 2 3 4 5}

Is the Esprit BTK Device safe for use in humans?

Research on similar devices like the PTA balloon catheter for critical limb ischemia (CLI) suggests that these treatments are generally considered safe, but complications such as restenosis (re-narrowing of the artery) and stent fractures can occur. Further studies are needed to fully understand the safety profile of these devices. ^{1 3 6 7 8}

How is the Esprit BTK Device treatment different from other treatments for critical limb ischemia?

The Esprit BTK Device is unique because it is specifically designed for use in the below-the-knee arteries, which are often affected in critical limb ischemia. Unlike traditional treatments like angioplasty or drug-eluting stents, this device may offer a novel approach to revascularization (restoring blood flow) in these challenging areas. ^{1 3 6 8 9}

Research Team

Ramon Varcoe

Principal Investigator

Prince of Wales Private Hospital, Randwick, NSW, Australia

Sahil Parikh

Principal Investigator

New York Presbyterian Hospital, New York, NY

Brian DeRubertis, MD, FACS

Principal Investigator

NewYork-Presbyterian/Weill Cornell Medical Center, New York, NY

Eligibility Criteria

This trial is for adults with Critical Limb Ischemia needing treatment for leg artery blockages. Participants must not be pregnant, on birth control if applicable, and have no severe kidney issues or recent strokes. They should not be part of another study or have conditions that could interfere with the trial.

Inclusion Criteria

The blood vessel being studied should not have any other major blockages.

My lesions are close together and can be covered with a single treatment.

I have severe leg pain from poor blood flow, classified as Category 4 or 5.

Exclusion Criteria

I am allergic to common blood thinners and cannot take them.

I am undergoing or scheduled for cancer treatment around the time of my procedure, but have been in remission for 6 months if on chemotherapy.

I had a stroke in the last 3 months and still have some disability.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Esprit BTK device or PTA treatment for narrowed infrapopliteal lesions

6 months

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of limb salvage and patency

1 year

Regular follow-up visits

Treatment Details

Interventions

• Esprit BTK Device
• Percutaneous Transluminal Angioplasty (PTA) Device

Trial Overview The LIFE-BTK trial tests the Esprit BTK System, a device releasing everolimus to treat narrowed arteries below the knee, against standard balloon angioplasty. It's randomized and single-blinded at multiple international sites with a 2:1 participant ratio favoring the test device.

Participant Groups

Group I: Esprit BTK Experimental Treatment 1 Intervention

Participants who receives Esprit BTK device will be included in this arm

Group II: Percutaneous Transluminal Angioplasty (PTA) Active Control 1 Intervention

Participants who receives PTA treatment will be included in this arm

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

Drug-coated devices, specifically drug-eluting stents (DES), show improved angiographic outcomes in treating below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI), compared to bare metal stents, particularly in terms of primary patency and restenosis rates.

Despite the promising angiographic results, clinical outcomes for DES in BTK revascularization remain unclear, and there are concerns about complications such as stent fractures that could lead to increased restenosis rates, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the use of drug eluting stents in below-the-knee lesions. Trombert, D., Caradu, C., Brizzi, V., et al.[2016]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Evidence for the use of drug eluting stents in below-the-knee lesions. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (Part 2: Below the knee). [2018]

3. Israel pubmed.ncbi.nlm.nih.gov

Changing Paradigms in Below-the-Knee Arterial Interventions: Are We Saving Legs? [2022]

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

Comparison of drug eluting balloon angioplasty to infrapopliteal artery critical lesions with or without additional pedal artery angioplasty in patients with diabetes mellitus and critical limb ischemia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Endovascular therapy as the primary approach for limb salvage in patients with critical limb ischemia: experience with 443 infrapopliteal procedures. [2017]

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

Revascularization for critical limb ischemia using the SpiderFX embolic protection device in the below-the-knee circulation: initial results. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Applicability and clinical results of percutaneous transluminal angioplasty with a novel, long, conically shaped balloon dedicated for below-the knee interventions. [2022]

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

Angioplasty for treatment of isolated below-the-knee arterial stenosis in patients with critical limb ischemia. [2011]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Below the knee intervention using multidisciplinary methods including an antegrade, retrograde approach without the use of a sheath but with a plaque excision device. [2021]