Esprit BTK Device for Critical Limb Ischemia

Not currently recruiting at 6 trial locations

Overseen By Rebecca Maslow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must not be taking: Anticoagulants, Immunosuppressants, Chemotherapy, others

Disqualifiers: Pregnancy, Stroke, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 0 to 60 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device treatment for individuals with critical limb ischemia, a condition causing severe blood flow issues in the legs. The study specifically examines the effectiveness of the Esprit BTK device in treating blockages in the arteries below the knee. Participants may qualify if they experience ongoing symptoms from this condition and require treatment for artery blockages in their legs. The trial aims to assess the device's effectiveness with and without drug-coated balloons. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance treatment options for critical limb 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, if you have allergies or contraindications to certain medications 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 critical limb ischemia?

Studies have shown that the Esprit BTK device is generally well-tolerated in patients with severe leg artery disease. Research indicates that people treated with this device experienced a significant reduction in severe leg artery problems compared to those who received standard balloon treatment. Two-year results from the LIFE-BTK trial demonstrated lasting benefits and good long-term performance of the device. Serious side effects were uncommon, and the device improved blood flow in the legs, which is crucial for healing. While no treatment is without risks, the available data suggest this device is relatively safe for its intended use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Esprit BTK device because it offers a novel approach for treating critical limb ischemia. Unlike traditional treatments such as bypass surgery or drug-coated balloons, which primarily focus on restoring blood flow, the Esprit BTK device is a bioresorbable scaffold that provides temporary support to the artery before safely dissolving over time. This innovative feature minimizes long-term complications associated with permanent implants and allows the artery to heal naturally, potentially improving outcomes for patients.

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 will receive, may help treat critical limb ischemia, a condition where blood flow to the legs is severely reduced. In one study, 61.5% of patients using the Esprit BTK saved their limbs from amputation and kept their arteries open, compared to only 32.8% with other treatments. After two years, results showed that the Esprit BTK device maintained open arteries and prevented blockages more effectively than other treatments. This device is designed to improve blood flow and healing in the lower leg, potentially reducing the need for amputations. These findings suggest that the Esprit BTK device could be an effective option for patients with this serious condition. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with symptomatic Critical Limb Ischemia, specifically Rutherford Becker Clinical Category 4 or 5. Participants must have specific types of leg artery blockages and be able to undergo the procedure as described. Pregnant women, those on certain other medications, or with conditions like severe allergies to device materials, recent strokes, renal insufficiency, or a short life expectancy cannot join.

Inclusion Criteria

My non-targeted leg vein issues can be treated without affecting the main treatment area.

My treatment area is well above my ankle and any narrowings below it have been treated.

I've had successful treatment for a major blockage in my artery before joining this trial.

Exclusion Criteria

You have a metal stent implanted in the area of concern.

I have untreated or unsuccessfully treated artery blockages near my heart.

Note: staged procedures are not allowed in LIFE-BTK PK sub-study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Esprit BTK device treatment in below the knee artery(ies)

0 to 60 days

Multiple visits for blood analyte concentration assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Esprit BTK Device

Trial Overview The LIFE-BTK PK Sub-study is testing the Esprit BTK Device in patients who haven't used drug-coated balloons (DCB) and those who have. It's not randomized; about seven people will get this device implanted in their below-the-knee arteries at up to five sites in the US.

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

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. 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 ...

2. 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 ...

3. 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 ...

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. 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 From ... 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 ...

6. abbott.mediaroom.com abbott.mediaroom.com/press-releases?item=124676

Abbott MediaRoom - Press Releases Compared to balloon angioplasty, people treated with Esprit BTK had significantly greater freedom from chronic limb-threatening ischemia (a ...