Critical Limb Ischemia (CLI)LIFE-BTKNCT04227899

LIFE-BTK Randomized Controlled Trial

A study testing Esprit BTK Device and Percutaneous Transluminal Angioplasty (PTA) Device in people with Critical Limb Ischemia (CLI), run by Abbott Medical Devices at 50 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Limb Ischemia (CLI)
What is being tested?: Esprit BTK Device and Percutaneous Transluminal Angioplasty (PTA) Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 261 participants
Where: 50 sitesin 6 countries
Study dates: 18 Aug 2020to Jul 2027
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

General Inclusion Criteria:
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.

Show all 19Show fewer

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.
Anatomic Inclusion Criteria:
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.
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.
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.

Who cannot join

General Exclusion Criteria:
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.

Show all 45Show fewer

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.
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.
Subject who requires thrombolysis as a primary treatment modality or requires other treatment for acute limb ischemia of the target limb.
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.
Subject has signs or symptoms of advanced limb infection or septicemia (fever > 38.5, WBC > 15,000 cells/microliter, hypotension) at the time of assessment. Osteomyelitis of the phalanges or metatarsal heads (as described in exclusion criteria #21a) or cellulitis of the foot amenable to treatment with IV antibiotics at the time of revascularization is acceptable.
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.
Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations. This includes subjects with:
Osteomyelitis that extends proximal to the metatarsal heads. Osteomyelitis limited to the phalanges or metatarsal heads is acceptable for enrollment.
Gangrene involving the plantar skin of the forefoot, midfoot, or heel.
Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel.
Full thickness heel ulcer with/without calcaneal involvement.
Any wound with calcaneal bone involvement.
Wounds that are deemed to be neuropathic or non-ischemic in nature.
Wounds that would require flap coverage or complex wound management for large soft tissue defect.
Full thickness wounds on the dorsum of the foot with exposed tendon or bone.
Subject is unable or unwilling to provide written consent prior to enrollment.
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.
Anatomic Exclusion Criteria:
Lesions with severe calcification, in which there is a high likelihood that successful pre-dilatation cannot be achieved.
Lesion that has prior metallic stent implant.
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.
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.
Target or (if applicable) non-target vessel contains visible thrombus as indicated in the angiographic images.
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).
Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
No angiographic evidence of a patent pedal artery.
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).
Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity.
Visual assessment of the target lesion suggests that the investigator is unable to pre-dilate the lesion according to the vessel diameter.
Target lesion has a high probability that atherectomy will be required at the time of index procedure for treatment of the target vessel.

Trial locations and contacts

50 sites in 6 countries.

Country

City, postcode or hospital

50 sites in 6 countries

United States43 sites

Anmed Health
Anderson, South Carolina, 29621
Piedmont Heart Institute
Atlanta, Georgia, 30309
University of Colorado Hospital
Aurora, Colorado, 80045
Ascension St. John Jane Phillips
Bartlesville, Oklahoma, 74006
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Manatee Memorial Hospital
Bradenton, Florida, 34208
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
Lankenau Institute for Medical Research
Bryn Mawr, Pennsylvania, 19096
University of Chicago Medical Center
Chicago, Illinois, 60637
The Lindner Center
Cincinnati, Ohio, 45255
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
St. Helena Hospital
Deer Park, California, 94574
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania, 16502
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104
Mission Cardiovascular Research Institute
Fremont, California, 94538
UCSF Fresno
Fresno, California, 93701
Comprehensive Integrated Care
Gilbert, Arizona, 85233
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Jackson Heart Clinic
Jackson, Mississippi, 39216
First Coast Cardiovascular Institute
Jacksonville, Florida, 32218
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Texas Tech University Health Sciences Center at Lubbock
Lubbock, Texas, 79430
Palm Vascular Centers
Miami Beach, Florida, 33140
Yale New Haven Hospital
New Haven, Connecticut, 06510
NYU Langone Health
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
New York Presbyterian Hospital/Cornell University
New York, New York, 10065
St. Joseph Hospital
Orange, California, 92868
Vascular Institute of Atlantic Medical Imaging
Pomona, New Jersey, 08240
NC Heart & Vascular Research
Raleigh, North Carolina, 27607
Charlton Memorial Hospital
Russells Mills, Massachusetts, 02720
San Antonio Vascular and Endovascular Clinic
San Antonio, Texas, 78221
Tallahassee Research Institute
Tallahassee, Florida, 32308
Holy Name Medical Center
Teaneck, New Jersey, 07666
James J. Peters VA Medical Center
The Bronx, New York, 10468
The Iowa Clinic
West Des Moines, Iowa, 50266
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, 67226
Pinnacle Health System
Wormleysburg, Pennsylvania, 17043

Other trials in United States

Australia2 sites

Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Prince of Wales Private Hospital
Randwick, New South Wales, 2031

Other trials in Australia

Hong Kong2 sites

Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong

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New Zealand1 site

Auckland City Hospital
Auckland, Auckland, 1023

Other trials in New Zealand

Singapore1 site

Changi General Hospital
Singapore, 529889

Other trials in Singapore

Taiwan1 site

National Taiwan University Hospital
Taipei, Zhongzheng, 100

Other trials in Taiwan

About this study

Official title: LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial

Conditions: Critical Limb Ischemia (CLI)
Being tested: Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
Keywords: Infrapopliteal lesions, Esprit BTK Everolimus Eluting Bioresorbable Scaffold System, Percutaneous transluminal angioplasty (PTA), ABT-CIP-10293
Medical subject headings: Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Esprit BTK DeviceDevice
Participants will receive Esprit BTK Device
Percutaneous Transluminal Angioplasty (PTA) DeviceDevice
Participants will receive PTA treatment

Study groups in NCT04227899
Study group	Role	What they receive
Esprit BTK	Experimental	Participants who receives Esprit BTK device will be included in this arm Receives: Device: Esprit BTK Device
Percutaneous Transluminal Angioplasty (PTA)	Active comparator	Participants who receives PTA treatment will be included in this arm Receives: Device: Percutaneous Transluminal Angioplasty (PTA) Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: At 30 days (for POD) and 6 months (for MALE)

Secondary outcomes (2)

First Powered Secondary Endpoint: Binary Restenosis of the Target Lesion
This endpoint was added to better evaluate the device performance as binary restenosis was used as a marker for disease progression over time.
Measured: 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.
This endpoint was chosen as it was important to assess whether Esprit BTK System was efficacious at maintaining patency and preventing catastrophic limb events through 1 year.
Measured: At 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 2020Jul 2027

First posted14 Jan 2020
Study start18 Aug 2020
Primary completion17 Aug 2023
Study completionJul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Critical Limb Ischemia (CLI)Studies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04227899
Sponsor's protocol ID: ABT-CIP-10293
Acronym: LIFE-BTK
Status last verified: Dec 2025
First submitted: 6 Jan 2020
Last updated: 30 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Parikh SA, DeRubertis BG, Bonaca MP, Krishnan P, Pin RH, Lee JK, Metzger DC, Kolluri R, Shishehbor MH, Holden AH, Iida O, Armstrong E, Kum SWC, O'Connor DJ, Bajakian DR, Garcia LA, Ying SW, Wang J, Ruster K, Martinsen BJ, Igyarto Z, Varcoe RL. Long-Term Outcomes of a Drug-Eluting Resorbable Scaffold vs Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia: 3-Year Results From the LIFE-BTK Trial. J Am Coll Cardiol. 2026 Jul 7;88(1):95-109. doi: 10.1016/j.jacc.2026.04.008. Epub 2026 May 13.
PubMed 42126372
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.
PubMed 40927852
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.
PubMed 37888915

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Peripheral Arterial Disease, Critical Lower Limb Ischemia
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FAZA PET/MRI in CLI Patients Pre and Post Revascularization
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PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
Active, not recruiting
LIFE-BTK PK Sub-study
Critical Limb Ischemia (CLI)

All Critical Limb Ischemia (CLI) trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04227899
Acronym / sponsor ID: LIFE-BTK / ABT-CIP-10293
Conditions: Critical Limb Ischemia (CLI)
Keywords: Infrapopliteal lesions, Esprit BTK Everolimus Eluting Bioresorbable Scaffold System, Percutaneous transluminal angioplasty (PTA), ABT-CIP-10293
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 261 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 18 Aug 2020 (actual)
Primary completion: 17 Aug 2023 (actual)
Study completion: Jul 2027 (estimated)
First posted: 14 Jan 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Esprit BTK	Experimental	Device: Esprit BTK DeviceParticipants who receives Esprit BTK device will be included in this arm
Percutaneous Transluminal Angioplasty (PTA)	Active comparator	Device: Percutaneous Transluminal Angioplasty (PTA) DeviceParticipants who receives PTA treatment will be included in this arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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.

Key exclusion criteria (45 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Esprit BTK DeviceParticipants will receive Esprit BTK Device	Device	Esprit BTK
Percutaneous Transluminal Angioplasty (PTA) DeviceParticipants will receive PTA treatment	Device	Percutaneous Transluminal Angioplasty (PTA)

Primary outcome

Primary Efficacy Endpoint: Number of Participants With Composite of Limb Salvage and Primary Patency
Time frame: At 1 year
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).
Primary Safety Endpoint: Freedom From Major Adverse Limb Event + Peri-Operative Death Rate (MALE + POD)
Time frame: At 30 days (for POD) and 6 months (for MALE)
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.

2 secondary outcomes

First Powered Secondary Endpoint: Binary Restenosis of the Target Lesion
Time frame: 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.
Time frame: At 1 year

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esprit BTK	173	153
Percutaneous Transluminal Angioplasty (PTA)	88	78

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

Time frame: At 1 year. Count of participants. Unit: Participants

Measure	Esprit BTK n = 149	Percutaneous Transluminal Angioplasty (PTA) n = 71
Value	111	31

Esprit BTK vs Percutaneous Transluminal Angioplasty (PTA): p <0.0001, One-sided Chi-square test

Population analysed: Analysis excluded subjects who terminated from the study prior to the lower limit (337 days) of the 1-year primary efficacy endpoint follow-up window without any components of the primary endpoint, and subjects with no known endpoint event and who did not have analyzable duplex ultrasound or angiography for the 1-year imaging assessment.

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

Time frame: At 30 days (for POD) and 6 months (for MALE). Count of participants. Unit: Participants

Measure	Esprit BTK n = 160	Percutaneous Transluminal Angioplasty (PTA) n = 85
Value	155	85

Esprit BTK vs Percutaneous Transluminal Angioplasty (PTA): p = 0.0019, Farrington-Manning non-inferiority (NI)

Population analysed: Analysis excluded subjects who terminated from the study prior to the lower limit (152 days) of the 6-month primary safety endpoint follow-up window without any components of the primary endpoint.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esprit BTK	89 of 173 (51.4%)	105 of 173 (60.7%)	12 of 173
Percutaneous Transluminal Angioplasty (PTA)	45 of 88 (51.1%)	60 of 88 (68.2%)	6 of 88

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42126372Parikh SA, DeRubertis BG, Bonaca MP, Krishnan P, Pin RH, Lee JK, Metzger DC, Kolluri R, Shishehbor MH, Holden AH, Iida O, Armstrong E, Kum SWC, O'Connor DJ, Bajakian DR, Garcia LA, Ying SW, Wang J, Ruster K, Martinsen BJ, Igyarto Z, Varcoe RL. Long-Term Outcomes of a Drug-Eluting Resorbable Scaffold vs Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia: 3-Year Results From the LIFE-BTK Trial. J Am Coll Cardiol. 2026 Jul 7;88(1):95-109. doi: 10.1016/j.jacc.2026.04.008. Epub 2026 May 13.
Derived from this study: PubMed 40927852DeRubertis 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.
Derived from this study: PubMed 37888915Varcoe 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.
Individual participant dataSharing planned: No

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Recruiting
FAZA PET/MRI in CLI Patients Pre and Post Revascularization
Critical Limb Ischemia
Recruiting
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
Active, not recruiting
LIFE-BTK PK Sub-study
Critical Limb Ischemia (CLI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ramon L Varcoe, MBBS, MS, FRACS, PhD principal investigator

Prince of Wales Private Hospital, Randwick, NSW, Australia

Sahil Parikh, MD, FACC, FSCAI principal investigator

New York Presbyterian Hospital, New York, NY

Brian DeRubertis, MD, FACS principal investigator

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

50 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Esprit BTK Device and Percutaneous Transluminal Angioplasty (PTA) Device in people with Critical Limb Ischemia (CLI), run by Abbott Medical Devices at 50 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Australia, Hong Kong, New Zealand, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint: Number of Participants With Composite of Limb Salvage and Primary Patency (time frame: At 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04227899, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.