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:
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Conditions: Peripheral Artery DiseaseCritical Limb Ischemia (cli).
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Age: Between 18 years - 130 years
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Gender: Male or Female
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Other Inclusion Criteria:
General Inclusion Criteria:- Participants who will provide informed written consent
- Have symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5
- Requires primary treatment of up to two de novo or restenotic (treated with prior PTA) infrapopliteal lesions
- Female subject of childbearing potential should not be pregnant and must be on birth control
- Female subject of childbearing potential should not be pregnant and must be on birth control.
- Up to two native infrapopliteal lesions, each lesion located in separate infrapopliteal vessel in the same limb.
- Target lesion(s) must have = 70% stenosis, per visual assessment at the time of the procedure
- The distal margin of the target lesion must be located = 10 cm proximal to the proximal margin of the ankle mortise
- Significant lesion (= 50% stenosis) in the inflow artery(ies) must be treated successfully
- 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 lesion successfully in antegrade fashion
You may not be eligible for this study if the following are true:
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General Exclusion Criteria
- Currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the study participation
- 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
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority
- Has had any type of amputation to the ipsilateral extremity, or a contralateral extremity amputation other than the toe or forefoot.
- Has known hypersensitivity or contraindication to device material and its degradants
- Has known allergic reaction, hypersensitivity or contraindication to aspirin; or to ADP antagonists
- Has life expectancy = 1 year
- Has had a stroke within the previous 3 months with residual Rankin score of = 2
- Has renal insufficiency
- Currently on dialysis.
- Has known serious immunosuppressive disease has severe autoimmune disease, that requires chronic immunosuppressive therapy
- Body Mass Index (BMI) <18.
- Receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure
- Has coagulation disorder
- Who requires thrombolysis
- Has systemic or limb infection
- Bedridden or unable to walk
- Extensive tissue loss salvageable
- Unable or unwilling to provide written consent
- Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent
- Retrograde crossing of the guidewire
- Lesions with severe calcification
- Lesion that has prior metallic stent implant
- Significant (-= 50% stenosis) lesion in a distal outflow artery
- Inflow lesions or non-target infrapopliteal lesions t
- Has had or will require treatment in any peripheral anatomy vessel with a drug-coated or drug-eluting device
- Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
- No angiographic evidence of a patent pedal artery
- Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.