LIFE-BTK Randomized Controlled Trial

NCT04227899 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: ABT-CIP-10293
• Study Type: interventional
• Target: 261
• Locations: 6 countries
• Sites: 50

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

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: Number of Participants With Composite of Limb Salvage and Primary Patency

  This endpoint was to evaluate the effectiveness of the Esprit BTK System in maintaining patency (CD-TLR and binary restenosis), and at preventing catastrophic limb events such as total vessel occlusion or major amputation. Composite of Limb Salvage and Primary Patency included freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).

  At 1 year

• Primary Safety Endpoint: Freedom From Major Adverse Limb Event + Peri-Operative Death Rate (MALE + POD)

  The primary safety endpoint assessed the safety of the devices used for treatment of below the knee lesions. It included freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death). MALE includes above-ankle amputation in the index limb, major re-intervention on the index limb at 6 months and POD includes perioperative (30-day) mortality.

  At 30 days (for POD) and 6 months (for MALE)

Secondary Outcomes (2)

• First Powered Secondary Endpoint: Binary Restenosis of the Target Lesion

  At 1 year

• Second Powered Secondary Endpoint: Freedom From Above Ankle Amputation in Index Limb, 100% Total Occlusion of the Target Vessel, and CD-TLR.

  At 1 year

Study Arms (2)

Esprit BTK

EXPERIMENTAL

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

Device: Esprit BTK Device

Percutaneous Transluminal Angioplasty (PTA)

ACTIVE COMPARATOR

Participants who receives PTA treatment will be included in this arm

Device: Percutaneous Transluminal Angioplasty (PTA) Device

Interventions

Esprit BTK Device DEVICE

Participants will receive Esprit BTK Device

Esprit BTK

Percutaneous Transluminal Angioplasty (PTA) Device DEVICE

Participants will receive PTA treatment

Percutaneous Transluminal Angioplasty (PTA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide written informed consent prior to any clinical investigation related procedure.
• Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5.
• Subject requires primary treatment of up to two de novo or restenotic (treated with prior PTA) infrapopliteal lesions.
• Subject must be at least 18 years of age.
• 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.
• Up to two native infrapopliteal lesions, each lesion located in separate infrapopliteal vessel in the same limb. Restenotic (from prior PTA) lesions are allowed.
• 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.
• Total scaffold length to completely cover/treat a target lesion must not exceed 170 mm (total everolimus drug dose of 1790 µg).
• The total scaffold length among all target lesions must not exceed 170 mm.
• The target vessel cannot have any other angiographic significant lesions (≥50%).
• 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.
• 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.
• 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).
• 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.

You may not qualify if:

• Subject is currently participating in another clinical investigation that has not yet completed its primary endpoint.
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
• 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.
• Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
• 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.
• 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.
• 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.
• Subject has life expectancy ≤ 1 year.
• Subject has had a stroke within the previous 3 months with residual Rankin score of ≥ 2.
• Subject has renal insufficiency as defined as an estimated GFR \< 30 ml/min per 1.73m\^2.
• Subject is currently on dialysis.
• 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.
• 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.
• Subject has Body Mass Index (BMI) \<18.
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (50)

Comprehensive Integrated Care

Gilbert, Arizona, 85233, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

St. Helena Hospital

Deer Park, California, 94574, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

UCSF Fresno

Fresno, California, 93701, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32218, United States

Location

Palm Vascular Centers

Miami Beach, Florida, 33140, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67226, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Charlton Memorial Hospital

Russells Mills, Massachusetts, 02720, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Deborah Heart & Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Vascular Institute of Atlantic Medical Imaging

Pomona, New Jersey, 08240, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10065, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

The Lindner Center

Cincinnati, Ohio, 45255, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ascension St. John Jane Phillips

Bartlesville, Oklahoma, 74006, United States

Location

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, 19096, United States

Location

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, 16502, United States

Location

Pinnacle Health System

Wormleysburg, Pennsylvania, 17043, United States

Location

Anmed Health

Anderson, South Carolina, 29621, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, 76104, United States

Location

Texas Tech University Health Sciences Center at Lubbock

Lubbock, Texas, 79430, United States

Location

San Antonio Vascular and Endovascular Clinic

San Antonio, Texas, 78221, United States

Location

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

National Taiwan University Hospital

Taipei, Zhongzheng, 100, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 40927852 DERIVED

• 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.

  PMID: 37888915 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Karine Ruster
• Organization: Abbott

karine.piard-ruster@abbott.com

(408) 845-0764

Study Officials

• Ramon L Varcoe, MBBS, MS, FRACS, PhD

  Prince of Wales Private Hospital, Randwick, NSW, Australia

  PRINCIPAL INVESTIGATOR

• Sahil Parikh, MD, FACC, FSCAI

  New York Presbyterian Hospital, New York, NY

  PRINCIPAL INVESTIGATOR

• Brian DeRubertis, MD, FACS

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 14, 2020
• Study Start: August 18, 2020
• Primary Completion: August 17, 2023
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 30, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); NZ (1); AU (2); TW (1); HK (2); US (43)