United States, Australia, Taiwan9 participantsStarted 2022-02-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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).
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.
What they're measuring
1
Maximal Blood Everolimus Concentration (Cmax)
Timeframe: 0 to 60 days
2
Area Under the Blood Concentration Time Curve From Administration to the Concentration at 24 Hours (AUC0-24h)
Timeframe: 0 to 24 hours
3
Area Under the Blood Concentration Time Curve From Administration to Last Observed Concentration at Time t (AUCt)
Timeframe: 0 to 60 days
4
Area Under the Blood Everolimus Concentration vs. Time Curve From Time Zero and Extrapolated to Infinity (AUCinf)
Timeframe: 0 to 60 days
5
Time to Reach Maximum Observed Whole-Blood Concentration (Tmax)
. 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.