Esprit BTK Device for Critical Limb Ischemia

(LIFE-BTK Trial)

Not currently recruiting at 63 trial locations

Overseen By Lyssa Ochoa, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Esprit BTK for treating critical limb ischemia, a condition where severely reduced blood flow to the legs causes pain and sores. The study compares this new device to a standard treatment, Percutaneous Transluminal Angioplasty (PTA), which uses a small balloon to open blood vessels. The goal is to determine if the Esprit BTK device safely and effectively improves blood flow. Individuals with painful leg symptoms from critical limb ischemia who need treatment for up to two blocked vessels might be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could lead to new treatment options.

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 prior data suggests that the Esprit BTK Device is safe for treating narrowed infrapopliteal lesions?

Research has shown that the Esprit BTK Device was tested in earlier studies, including the LIFE-BTK trial. Results from this trial over two years indicated that patients generally tolerated the device well, with no major safety issues reported. The study found that the device effectively kept blood vessels open in the legs of patients with severe limb blood flow problems.

Although all medical devices carry risks, the Esprit BTK Device demonstrated encouraging safety results in these studies. This suggests it could be a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Esprit BTK device is unique because it offers a fresh approach to treating critical limb ischemia. Unlike traditional treatments like Percutaneous Transluminal Angioplasty (PTA), which primarily involve widening narrowed blood vessels, the Esprit BTK device is a bioresorbable scaffold designed to support the artery temporarily and then dissolve over time. Researchers are excited about this device because it aims to restore blood flow without leaving a permanent implant, potentially reducing long-term complications and re-interventions. This new method could lead to improved healing and better overall outcomes for patients suffering from this severe condition.

What evidence suggests that the Esprit BTK Device is effective for critical limb ischemia?

Research has shown that the Esprit BTK device, which participants in this trial may receive, could help treat severe artery blockages in the lower legs, known as critical limb ischemia. In one study, 61.5% of patients using this device avoided amputation and kept their arteries open after two years. This marked a significant improvement compared to 32.8% of patients who underwent Percutaneous Transluminal Angioplasty (PTA), another treatment option in this trial. The Esprit BTK device is designed to improve blood flow, aiding in healing and limb preservation more effectively than traditional methods. These results suggest the device could be a promising option for patients with narrowed arteries below the knee. ^{1 2 3 4 5}

Who Is on the Research Team?

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

Ramon Varcoe

Principal Investigator

Prince of Wales Private Hospital, Randwick, NSW, Australia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230036B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The applicant performed a clinical study (LIFE-BTK) to establish a reasonable assurance of safety and effectiveness of the revascularization ...

2. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/peripheral-intervention/esprit-btk-resorbable-scaffold-system.html

Esprit BTK Resorbable Scaffold System | Abbott Esprit BTK is a new paradigm for limb salvage intervention, creating opportunities for sustained patency and increased pedal perfusion pressure to heal the ...

3. evtoday.com evtoday.com/news/abbotts-esprit-btk-scaffold-evaluated-in-2-year-data-from-life-btk-trial

Abbott's Esprit BTK Scaffold Evaluated in 2-Year Data ... At 2 years, 61.5% of patients treated with Esprit BTK achieved the combined endpoint of limb salvage and primary patency compared to 32.8% in ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.075080

2-Year Results From the LIFE-BTK Trial | Circulation This report presents the 2-year outcomes from the LIFE-BTK trial, evaluating the safety and efficacy of the Esprit BTK scaffold in patients with ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40927852/

2-Year Results From the LIFE-BTK Trial Conclusions: At 2 years, the Esprit BTK DRS demonstrated improved efficacy compared with PTA in maintaining arterial patency, preventing ...