LIFE-BTK Randomized Controlled Trial

NCT ID: NCT04227899

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2027-07-31

Brief Summary

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.

Conditions

Critical Limb Ischemia (CLI)

Keywords

Infrapopliteal lesions; Esprit BTK Everolimus Eluting Bioresorbable Scaffold System; Percutaneous transluminal angioplasty (PTA); ABT-CIP-10293

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Esprit BTK

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

Group Type: EXPERIMENTAL

Esprit BTK Device

Intervention Type: DEVICE

Participants will receive Esprit BTK Device

Percutaneous Transluminal Angioplasty (PTA)

Participants who receives PTA treatment will be included in this arm

Group Type: ACTIVE_COMPARATOR

Percutaneous Transluminal Angioplasty (PTA) Device

Intervention Type: DEVICE

Participants will receive PTA treatment

Interventions

Esprit BTK Device

Participants will receive Esprit BTK Device

Intervention Type: DEVICE

Percutaneous Transluminal Angioplasty (PTA) Device

Participants will receive PTA treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject must provide written informed consent prior to any clinical investigation related procedure.

2. Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5.

3. Subject requires primary treatment of up to two de novo or restenotic (treated with prior PTA) infrapopliteal lesions.

4. Subject must be at least 18 years of age.

5. Female subject of childbearing potential should not be pregnant and must be on birth control.

Note: Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

1. Up to two native infrapopliteal lesions, each lesion located in separate infrapopliteal vessel in the same limb. Restenotic (from prior PTA) lesions are allowed.

1. Lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with vessel diameter of ≥ 2.5 mm and ≤ 4.00 mm by investigator visual assessment.

2. Total scaffold length to completely cover/treat a target lesion must not exceed 170 mm (total everolimus drug dose of 1790 µg).

3. The total scaffold length among all target lesions must not exceed 170 mm.

4. The target vessel cannot have any other angiographic significant lesions (≥50%).

5. Tandem lesions are allowed if they are < 3 cm apart and the total scaffold length used to cover the entire diseased segment is ≤ 170 mm. Each tandem lesion is considered one lesion.

2. Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography, IVUS, and/or OCT) can be used to aid accurate sizing of the vessels.

3. The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).

4. 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 can be done within the same trial procedure.

5. Non-target lesion(s) (if applicable) must be located in separate infrapopliteal vessel(s) from the target lesion, and suitable to be treated per institution standard of care.

6. Guidewire must cross the target lesion successfully. Crossing in an antegrade fashion is preferred, but retrograde crossing may be used. However, the treatment must be delivered antegrade.

Exclusion Criteria

1. Subject is currently participating in another clinical investigation that has not yet completed its primary endpoint.

2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.

4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.

5. Subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or subject has had major amputation to the contralateral extremity < 1 year prior to index procedure and is not independently ambulating.

6. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.

7. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to ADP antagonists such clopidogrel, prasugrel or ticagrelor; or to anticoagulants such as heparin or bivalirudin, and therefore cannot be adequately treated with study medications. Subject with planned surgery or procedure necessitating discontinuation of antiplatelet medications, within 12 months after index procedure. Planned amputation that will necessitate discontinuation of antiplatelet medications is allowed.

8. Subject has life expectancy ≤ 1 year.

9. Subject has had a stroke within the previous 3 months with residual Rankin score of ≥ 2.

10. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min per 1.73m^2.

11. Subject is currently on dialysis.

12. Subject has platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3, a WBC < 3,000 cells/mm^3, or hemoglobin < 9.0 g/dl.

13. Subject has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease, that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.), or subject is receiving immunosuppression therapy for other conditions. Subjects treated for HIV (Human Immunodeficiency Virus) and who have undetectable viral load, such that their immune system is not considered compromised, are eligible.

14. Subject has Body Mass Index (BMI) <18.

15. Subject is receiving or scheduled to receive anticancer therapy for malignancy within 6 months prior to index procedure or within 1 year after the procedure. Patients taking medications classified as chemotherapy but who have been in remission for at least 6 months are eligible.

16. Subject has coagulation disorder that increases the risk of arterial thrombosis. Subjects with deep vein thrombosis and disorders that increase the risk of deep vein thrombosis can be included in the study.

17. Subject who requires thrombolysis as a primary treatment modality or requires other treatment for acute limb ischemia of the target limb.

18. Subject has previously had, or requires surgical revascularization involving any vessel of the ipsilateral extremity. Prior femoropopliteal or aortobifemoral bypass is allowed. Any bypass to the tibial arteries is not allowed.

20. Subject is bedridden or unable to walk (with assistance is acceptable). Subjects in wheelchair who are able to mobilize on their own can be enrolled.

21. Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations. This includes subjects with:

1. Osteomyelitis that extends proximal to the metatarsal heads. Osteomyelitis limited to the phalanges or metatarsal heads is acceptable for enrollment.

2. Gangrene involving the plantar skin of the forefoot, midfoot, or heel.

3. Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel.

4. Full thickness heel ulcer with/without calcaneal involvement.

5. Any wound with calcaneal bone involvement.

6. Wounds that are deemed to be neuropathic or non-ischemic in nature.

7. Wounds that would require flap coverage or complex wound management for large soft tissue defect.

8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone.

22. Subject is unable or unwilling to provide written consent prior to enrollment.

23. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months.

1. Lesions with severe calcification, in which there is a high likelihood that successful pre-dilatation cannot be achieved.

2. Lesion that has prior metallic stent implant.

3. Significant (≥ 50% stenosis) lesion in a distal outflow artery that would be perfused by the target vessel and that requires treatment at the time of the index procedure.

4. Subject has had or will require treatment in any vessel with an everolimus drug-coated or drug-eluting device < 30 days pre-study procedure, or during the index procedure, such that the cumulative (Esprit BTK plus everolimus-eluting device) everolimus drug dose exceeds 1790 μg.

5. Target or (if applicable) non-target vessel contains visible thrombus as indicated in the angiographic images.

6. Subject has angiographic evidence of thromboembolism or atheroembolism in the ipsilateral extremity. (Pre- and post-angiographic imaging must confirm the absence of emboli in the distal anatomy).

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

8. No angiographic evidence of a patent pedal artery.

9. Target or (if applicable) non-target lesion location requiring bifurcation treatment method that requires scaffolding of both branches (provisional treatment, without intention of scaffolding both branches is acceptable).

10. Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity.

11. Visual assessment of the target lesion suggests that the investigator is unable to pre-dilate the lesion according to the vessel diameter.

12. Target lesion has a high probability that atherectomy will be required at the time of index procedure for treatment of the target vessel.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramon L Varcoe, MBBS, MS, FRACS, PhD

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Private Hospital, Randwick, NSW, Australia

Sahil Parikh, MD, FACC, FSCAI

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital, New York, NY

Brian DeRubertis, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Comprehensive Integrated Care

Gilbert, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

St. Helena Hospital

Deer Park, California, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

UCSF Fresno

Fresno, California, United States

St. Joseph Hospital

Orange, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Manatee Memorial Hospital

Bradenton, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Palm Vascular Centers

Miami Beach, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

The Iowa Clinic

West Des Moines, Iowa, United States

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Charlton Memorial Hospital

Russells Mills, Massachusetts, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Deborah Heart & Lung Center

Browns Mills, New Jersey, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Vascular Institute of Atlantic Medical Imaging

Pomona, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

NYU Langone Health

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

New York-Presbyterian/Columbia University Medical Center

New York, New York, United States

New York Presbyterian Hospital/Cornell University

New York, New York, United States

James J. Peters VA Medical Center

The Bronx, New York, United States

NC Heart & Vascular Research

Raleigh, North Carolina, United States

The Lindner Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ascension St. John Jane Phillips

Bartlesville, Oklahoma, United States

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, United States

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, United States

Pinnacle Health System

Wormleysburg, Pennsylvania, United States

Anmed Health

Anderson, South Carolina, United States

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, United States

Texas Tech University Health Sciences Center at Lubbock

Lubbock, Texas, United States

San Antonio Vascular and Endovascular Clinic

San Antonio, Texas, United States

Prince of Wales Private Hospital

Randwick, New South Wales, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Prince of Wales Hospital

Hong Kong, , Hong Kong

Queen Mary Hospital

Hong Kong, , Hong Kong

Auckland City Hospital

Auckland, Auckland, New Zealand

Changi General Hospital

Singapore, , Singapore

National Taiwan University Hospital

Taipei, Zhongzheng, Taiwan

Countries

United States; Australia; Hong Kong; New Zealand; Singapore; Taiwan

References

DeRubertis BG, Varcoe RL, Krishnan P, Bonaca MP, O'Connor DJ, Pin R, Metzger DC, Holden A, Lee JK, Iida O, Armstrong EJ, Kum SWC, Kolluri R, Bajakian DR, Garcia LA, Shishehbor MH, Yu S, Ruster K, Martinsen BJ, Igyarto Z, Parikh SA. Drug-Eluting Resorbable Scaffold Versus Balloon Angioplasty for Below-the-Knee Peripheral Artery Disease: 2-Year Results From the LIFE-BTK Trial. Circulation. 2025 Oct 14;152(15):1076-1086. doi: 10.1161/CIRCULATIONAHA.125.075080. Epub 2025 Sep 10.

Reference Type: DERIVED

PMID: 40927852 (View on PubMed)

Varcoe RL, DeRubertis BG, Kolluri R, Krishnan P, Metzger DC, Bonaca MP, Shishehbor MH, Holden AH, Bajakian DR, Garcia LA, Kum SWC, Rundback J, Armstrong E, Lee JK, Khatib Y, Weinberg I, Garcia-Garcia HM, Ruster K, Teraphongphom NT, Zheng Y, Wang J, Jones-McMeans JM, Parikh SA; LIFE-BTK Investigators. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Engl J Med. 2024 Jan 4;390(1):9-19. doi: 10.1056/NEJMoa2305637. Epub 2023 Oct 25.

Reference Type: DERIVED

PMID: 37888915 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10293

Identifier Type: -

Identifier Source: org_study_id