LIFE-BTK PK Sub-study

NCT05208905 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: ABT-CIP-10293 Ver. B
• Study Type: interventional
• Target: 9
• Locations: 3 countries
• Sites: 5

Brief Summary

LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside the US with a maximum of 5 sites in the US. Of the 7 subjects planned to be enrolled, 4 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom drug-coated balloons (DCB) were not used; 3 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom DCB were used for treatment of inflow disease.

Conditions

Critical Limb Ischemia (CLI)

Keywords

Infrapopliteal lesions; Esprit BTK Everolimus Eluting Bioresorbable Scaffold System

Outcome Measures

Primary Outcomes (6)

• Maximal Blood Everolimus Concentration (Cmax)

  Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 60 day period of the study after assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).

  0 to 60 days

• Area Under the Blood Concentration Time Curve From Administration to the Concentration at 24 Hours (AUC0-24h)

  Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post Esprit BTK implantation. Calculated by the Lin Up Log Down trapezoidal method.

  0 to 24 hours

• Area Under the Blood Concentration Time Curve From Administration to Last Observed Concentration at Time t (AUCt)

  Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.

  0 to 60 days

• Area Under the Blood Everolimus Concentration vs. Time Curve From Time Zero and Extrapolated to Infinity (AUCinf)

  Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ \* 100

  0 to 60 days

• Time to Reach Maximum Observed Whole-Blood Concentration (Tmax)

  Time to reach the maximal observed blood analyte concentration during the 60 day period of the study after assessing at different time frames (0 minute,10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).

  0 to 60 days

• Terminal Elimination Half-life (t1/2term)

  The apparent terminal elimination half-life, reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). calculated as: t1/2term = 0.693/λz.

  0 to 60 days

Study Arms (1)

Esprit BTK

EXPERIMENTAL

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

Device: Esprit BTK Device

Interventions

Esprit BTK Device DEVICE

Participants will receive Esprit BTK Device

Esprit BTK

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 one or more 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.
• One or more native infrapopliteal lesions, including de novo lesions 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 target lesion(s) must be between 170 and 256 mm (maximum total everolimus drug dose of 2714 µg).
• The target vessel can have any other angiographic significant lesions (≥50%) that should be treated per institution standard of care prior to treatment of the target lesion.
• Tandem lesions are allowed and the total scaffold length used to cover the entire diseased segment must be ≤ 256 mm.
• 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 scaffold must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. If the vessel segment distal to the target lesion has a significant lesion (\> 50% stenosis), it should be treated per institution standard of care prior to deployment of the scaffold.
• 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.
• It is acceptable for non-target lesion(s) (if applicable) to be located in the same infrapopliteal vessel(s) as the target lesion, and suitable to be treated per institution standard of care. Non-target lesions must be treated successfully prior to target lesions and not requiring re-cross of the scaffold.
• Crossing of the target lesion in an antegrade fashion is preferred, but retrograde crossing may be used. However, the treatment must be delivered antegrade.

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 (5)

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Charlton Memorial Hospital

South Dartmouth, Massachusetts, 02747, United States

Location

Ascension St. John Jane Phillips

Bartlesville, Oklahoma, 74006, United States

Location

Sir Charles Gairdner Hospital

Nedlands, WAUS, Australia

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

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

Results Point of Contact

• Title: Stacy Scribner
• Organization: Abbott

Stacy.Scribner@Abbott.com

+1 612 396 5353

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 26, 2022
• Study Start: February 10, 2022
• Primary Completion: April 18, 2023
• Study Completion (Estimated): February 22, 2028
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Locations

TW (1); US (3); AU (1)