Esprit BTK Device for Critical Limb Ischemia

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

9 Participants Needed

Trial Summary

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

Research shows that drug-eluting stents (DES), which are similar to the Esprit BTK Device, have been effective in improving blood flow in below-the-knee arteries for patients with critical limb ischemia. These stents have shown better results in keeping arteries open compared to other methods, although more studies are needed to confirm their long-term benefits. ^{1 2 3 4 5}

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 drug-eluting stents or balloon angioplasty, this device may offer a novel approach to revascularization (restoring blood flow) in these challenging areas. ^{1 2 6 7 8}

What is the purpose of this trial?

This trial tests Esprit BTK, a device for treating arteries below the knee. It targets patients with artery issues in this area, especially those not fully helped by other treatments. The device works by keeping the arteries open to improve blood flow.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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. Israel pubmed.ncbi.nlm.nih.gov

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

3. 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]

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

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

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. 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]

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]