What is the mechanism of action of this treatment?

Critical Limb Ischemia (CLI) is often treated with revascularization techniques such as angioplasty and stenting to restore blood flow. The Esprit BTK bioabsorbable scaffold is designed to provide temporary mechanical support to the artery, gradually dissolving over time. This approach aims to reduce long-term complications associated with permanent stents, such as chronic inflammation and restenosis. For CLI patients, this is crucial as it potentially lowers the risk of future interventions and improves long-term limb salvage and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Critical Limb Ischemia (CLI) include bioabsorbable scaffolds, drug-coated balloons (DCB), and percutaneous transluminal angioplasty (PTA). The known side effects of these treatments can include restenosis (re-narrowing of the artery), infection at the site of intervention, thrombosis (blood clot formation), and potential allergic reactions to the materials used in the devices. Bioabsorbable scaffolds, like the Esprit BTK, are designed to gradually dissolve, potentially reducing long-term complications associated with permanent stents, but they may still carry risks of early mechanical failure or incomplete absorption.

What other types of research exist?

Promising novel alternatives to Esprit BTK for Critical Limb Ischemia patients in 2024 include: 1) Drug-coated balloons (DCBs) which deliver antiproliferative drugs to the arterial wall to prevent restenosis, 2) Newer bioabsorbable scaffolds with improved design and drug-eluting capabilities, and 3) Advanced endovascular therapies such as atherectomy devices combined with DCBs to enhance vessel patency and reduce the need for repeat interventions.

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Device

Esprit BTK Device for Critical Limb Ischemia

Q: What prior FDA approvals exist?

The FDA has approved several treatments for Critical Limb Ischemia (CLI), including bioabsorbable scaffolds similar to the Esprit BTK. One notable approval is the Absorb GT1 Bioresorbable Vascular Scaffold System, which provides temporary mechanical support to the artery and gradually dissolves, potentially reducing long-term complications associated with permanent stents. Additionally, drug-coated balloons (DCBs) have been approved for use in peripheral artery disease, offering another treatment modality by delivering antiproliferative drugs to the arterial wall to prevent restenosis. These advancements aim to improve outcomes and reduce the need for repeat interventions in patients with CLI.

N/A

Waitlist Available

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment of the angiography) through standard of care prior to the treatment of the target lesion. Treatment must be done within the same trial procedure. Treatment allowed for inflow artery lesions are PTA, atherectomy, cutting/scoring balloon, Shockwave balloon, bare metal stent, drug-eluting stents or drug-coated balloon. Everolimus-coated or eluting devices are not allowed.

Subject must be at least 18 years of age

Must not have

Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.

Any wound with calcaneal bone involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 60 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for this sub-study, potential risks may include reactions to device materials such as everolimus and polymers used in the scaffold, bleeding due to antiplatelet medication requirements post-procedure, infection risk from surgery and local irritation or inflammation at implant site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I am not pregnant and am using birth control.

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My lesion is in the upper part of my lower leg's main arteries and is between 2.5 and 4.00 mm wide.

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

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I need treatment for a new or previously treated blockage below my knee.

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My treatment requires a specific device length to cover the affected area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My wound affects the heel bone.

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I have deep foot wounds exposing tendon or bone.

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My doctor thinks I'll likely need a procedure to remove plaque from my artery.

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I have a large sore (> 3 cm) on the bottom of my foot.

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I am mentally capable and have the legal right to make my own decisions.

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My condition involves severely calcified lesions that are hard to treat.

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I have an aneurysm in a major artery of my leg.

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I have a wound that needs complex care or surgery to cover.

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My kidney function is low, with a GFR under 30.

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My wound is caused by nerve damage and not by poor blood flow.

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I am currently undergoing dialysis.

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I need treatment for a blocked artery in my limb.

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

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I have had an amputation other than toe or forefoot on one side, or a major amputation on the opposite side within the last year and cannot walk on my own.

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I am allergic to certain materials like everolimus and metals used in medical devices that can't be managed with medication.

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I have a deep heel ulcer that may or may not affect the heel bone.

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I need complex foot surgery due to extensive tissue loss.

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I have a severe infection in my limb with fever, high white cell count, or low blood pressure.

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My foot's main artery is not open.

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I have gangrene on the bottom of my foot.

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I have had COVID-19 symptoms or a positive test within the last 2 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC 0-infinity

AUC Last/AUC0-t

AUC0-24h

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Esprit BTKExperimental Treatment1 Intervention

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

0 / 29Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Critical Limb Ischemia (CLI) is often treated with revascularization techniques such as angioplasty and stenting to restore blood flow. The Esprit BTK bioabsorbable scaffold is designed to provide temporary mechanical support to the artery, gradually dissolving over time. This approach aims to reduce long-term complications associated with permanent stents, such as chronic inflammation and restenosis. For CLI patients, this is crucial as it potentially lowers the risk of future interventions and improves long-term limb salvage and quality of life.

Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention.