Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Leigh Ann O'Banion

Description

Summary

Pre-market clinical evaluation of the everolimus eluting Esprit™ BTK System for the planned treatment of narrowed infrapopliteal lesions.

Official Title

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

Keywords

Critical Limb Ischemia (CLI) Infrapopliteal lesions Esprit BTK Everolimus Eluting Bioresorbable Scaffold System Percutaneous transluminal angioplasty (PTA) ABT-CIP-10293 Ischemia Esprit BTK Device Percutaneous Transluminal Angioplasty (PTA) Device Esprit BTK

Eligibility

You can join if…

Open to people ages 18 years and up

General Inclusion Criteria:

  1. Subject must provide written informed consent prior to any clinical investigation related procedure.
  2. Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5.
  3. Subject requires primary treatment of up to two de novo or restenotic (treated with prior PTA) infrapopliteal lesions
  4. Subject must be at least 18 years of age.
  5. 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.

Anatomic Inclusion Criteria:

  1. Up to two native infrapopliteal lesions, each lesion located in separate infrapopliteal vessel in the same limb. Restenotic (from prior PTA) lesions are allowed.
  2. 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.
  3. Total scaffold length to completely cover/treat a target lesion must not exceed 170 mm (total everolimus drug dose of 1790 µg).
  4. The total scaffold length among all target lesions must not exceed 170 mm.
  5. The target vessel cannot have any other angiographic significant lesions (≥50%).
  6. 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.
  7. 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.
  8. 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).
  9. 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
  10. 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.
  11. 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.

You CAN'T join if...

General Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation that has not yet completed its primary endpoint.
  2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
  3. 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.
  4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
  5. Subject has had any amputation to the ipsilateral, or contralateral extremity other than the toe or forefoot.
  6. 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.
  7. 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.
  8. Subject has life expectancy ≤ 1 year.
  9. Subject has had a stroke within the previous 3 months with residual Rankin score of ≥
  10. . Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min per 1.73m2.

  11. . Subject is currently on dialysis.
  12. . Subject has platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC < 3,000 cells/mm3, or hemoglobin < 9.0 g/dl.

  13. . 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.
  14. . Subject has Body Mass Index (BMI) <18.
  15. . Subject is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure.
  16. . Subject has coagulation disorder.
  17. . Subject who requires thrombolysis as a primary treatment modality or requires other treatment for acute limb ischemia of the target limb.
  18. . 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.
  19. . 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.
  20. . Subject is bedridden or unable to walk (with assistance is acceptable).
  21. . Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations. This includes subjects with:
  22. Osteomyelitis that extends proximal to the metatarsal heads. Osteomyelitis limited to the phalanges or metatarsal heads is acceptable for enrollment.
  23. Gangrene involving the plantar skin of the forefoot, midfoot, or heel
  24. Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel
  25. Full thickness heel ulcer with/without calcaneal involvement
  26. Any wound with calcaneal bone involvement
  27. Wounds that are deemed to be neuropathic or non-ischemic in nature
  28. Wounds that would require flap coverage or complex wound management for large soft tissue defect
  29. Full thickness wounds on the dorsum of the foot with exposed tendon or bone.
  30. . Subject is unable or unwilling to provide written consent prior to enrollment
  31. . 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:

  1. Lesions with severe calcification, in which there is a high likelihood that successful pre-dilatation cannot be achieved.
  2. Lesion that has prior metallic stent implant.
  3. 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.
  4. Inflow lesions or non-target infrapopliteal lesions that were treated using paclitaxel coated or eluting stents or DCB, during the index procedure.
  5. Subject has had or will require treatment in any peripheral anatomy vessel with a drug-coated or drug-eluting device < 90 days pre-study procedure.
  6. Target or (if applicable) non-target vessel contains visible thrombus as indicated in the angiographic images.
  7. 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.)
  8. Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
  9. No angiographic evidence of a patent pedal artery.
  10. . 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).
  11. . Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity.
  12. . Visual assessment of the target lesion suggests that the investigator is unable to pre-dilate the lesion according to the vessel diameter.
  13. . Target lesion has a high probability that atherectomy will be required at the time of index procedure for treatment of the target vessel.

Locations

  • UCSF Fresno accepting new patients
    Fresno California 93711 United States
  • Mission Cardiovascular Research Institute accepting new patients
    Fremont California 94538 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT04227899
Study Type
Interventional
Last Updated