LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS treatment-Below The Knee) Randomized Controlled Trial

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Peripheral Artery Disease
    Critical Limb Ischemia (cli).
  • Age: Between 18 - 130 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    General Inclusion Criteria:
    1. Participants who will provide informed written consent
    2. Have symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5
    3. Requires primary treatment of up to two de novo or restenotic (treated with prior PTA) infrapopliteal lesions
    4. Female subject of childbearing potential should not be pregnant and must be on birth control
    5. Female subject of childbearing potential should not be pregnant and must be on birth control.
    Anatomic Inclusion Criteria:
    1. Up to two native infrapopliteal lesions, each lesion located in separate infrapopliteal vessel in the same limb.
    2. Target lesion(s) must have = 70% stenosis, per visual assessment at the time of the procedure
    3. The distal margin of the target lesion must be located = 10 cm proximal to the proximal margin of the ankle mortise
    4. Significant lesion (= 50% stenosis) in the inflow artery(ies) must be treated successfully
    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 lesion successfully in antegrade fashion

You may not be eligible for this study if the following are true:

  • General Exclusion Criteria
    1. Currently participating in another clinical investigation
    2. Pregnant or nursing subjects and those who plan pregnancy during the study participation
    3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the participant’s ability to participate
    4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority
    5. Has had any type of amputation to the ipsilateral extremity, or a contralateral extremity amputation other than the toe or forefoot.
    6. Has known hypersensitivity or contraindication to device material and its degradants
    7. Has known allergic reaction, hypersensitivity or contraindication to aspirin; or to ADP antagonists
    8. Has life expectancy = 1 year
    9. Has had a stroke within the previous 3 months with residual Rankin score of = 2
    10. Has renal insufficiency
    11. Currently on dialysis.
    12. Has known serious immunosuppressive disease has severe autoimmune disease, that requires chronic immunosuppressive therapy
    13. Body Mass Index (BMI) <18.
    14. Receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure
    15. Has coagulation disorder
    16. Who requires thrombolysis
    17. Has systemic or limb infection
    18. Bedridden or unable to walk
    19. Extensive tissue loss salvageable
    20. Unable or unwilling to provide written consent
    21. Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent
    Anatomic Exclusion Criteria
    1. Retrograde crossing of the guidewire
    2. Lesions with severe calcification
    3. Lesion that has prior metallic stent implant
    4. Significant (-= 50% stenosis) lesion in a distal outflow artery
    5. Inflow lesions or non-target infrapopliteal lesions t
    6. Has had or will require treatment in any peripheral anatomy vessel with a drug-coated or drug-eluting device
    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. Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity



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