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LIFE-BTK Randomized Controlled Trial (LIFE-BTK)

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ClinicalTrials.gov Identifier: NCT04227899
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
Pre-market clinical evaluation of the everolimus eluting ESPRIT™ BTK System for the planned treatment of narrowed infrapopliteal lesions.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia (CLI) Device: ESPRIT™ BTK Device Device: Percutaneous Transluminal Angioplasty (PTA) Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 25, 2026

Arm Intervention/treatment
Experimental: ESPRIT™ BTK
Participants who receives ESPRIT™ BTK device will be included in this arm
Device: ESPRIT™ BTK Device
Participants will receive ESPRIT™ BTK Device

Active Comparator: Percutaneous Transluminal Angioplasty (PTA)
Participants who receives PTA treatment will be included in this arm
Device: Percutaneous Transluminal Angioplasty (PTA) Device
Participants will receive PTA treatment




Primary Outcome Measures :
  1. Composite of Limb Salvage and Primary Patency at 6 Months [ Time Frame: At 6 months ]
    It includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).

  2. Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 6 months (for MALE) ]
    MALE includes above ankle amputation in index limb, major re-intervention at 6 months and POD includes perioperative (30 day) mortality.


Secondary Outcome Measures :
  1. Number of Participants with Acute Procedure Success [ Time Frame: Immediately after the procedure ]
    Successful target lesion treatment is defined as final diameter stenosis < 30% with final number of run-off vessels equivalent to or greater than number of run-off vessels at pre-procedure, with no residual dissection NHLBI grade ≥ type C, and no transient or sustained angiographic complications (e.g. distal embolization, perforation, thrombosis). Achieved using balloons plus ESPRIT BTK in the treatment arm and balloons in the control arm. This is defined on a per lesion basis.

  2. Number of Participants with Device Success [ Time Frame: During the procedure ]
    Device success is defined on a per device basis, as the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

  3. Number of Participants with Technical Success [ Time Frame: During the procedure ]
    Technical success is defined on a per lesion basis as the attainment of a final residual stenosis of < 30% at the intended target lesion(s) following use of the study device(s). Standard pre-dilatation catheters and post-dilatation catheters (if applicable) may be used. Bailout at lesion level does not impact technical success if the above criteria are met.

  4. Number of Participants with Clinical Success [ Time Frame: Within 2 days after the index procedure or at hospital discharge ]
    Clinical success is defined on a per patient basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.

  5. Number of Participants with Angiographic acute gain (in-segment) [ Time Frame: Immediately after the procedure ]
    Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD).

  6. Number of Participants with Angiographic acute gain (in-device) [ Time Frame: Immediately after the procedure ]
    Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD). Angiographic acute gain (in-device) will be assessed for ESPRIT arm only

  7. Composite of Limb Salvage and Primary Patency [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
    Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).

  8. Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
    MALE includes above ankle amputation in index limb, major re-interventions at 1 month, 3 months, 6 months, 1 year and annually through 5 years, and POD includes perioperative (30 day) mortality.

  9. Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
  10. Freedom From Above Ankle Amputation [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
  11. Freedom From Restenosis [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
    Freedom from re-narrowing of the artery following the alleviation of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by angiography.

  12. Number of Amputation-free Survival [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
  13. Number of All-cause Death [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
    All-cause Death composed of cardiac death, vascular death and non-cardiovascular death

  14. Number of Participants with Arterial Thrombosis [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]

    Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.

    • Acute thrombosis: 0 - 24 hours post study procedure
    • Subacute thrombosis: > 24 hours - 30 days post study procedure
    • Late thrombosis: 31 days - 1 year post-procedure
    • Very late thrombosis: > 1 year post-procedure Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.

  15. Number of Participants with Major Re-intervention on index limb [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
    Major Limb Re-interventions includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization

  16. Primary Assisted Patency [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
    Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis

  17. Secondary Patency [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
    Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion

  18. Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
    CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography

  19. Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
  20. Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
  21. Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 1 month, 3 months, 6 months, 1 year and annually through 5 years ]
  22. Target Wound Assessment for Healing [ Time Frame: At 14 days, 30 days, 42 days and 90 days ]
    Wound assessment will be performed to determine whether the wound is improving (i.e. healing), not changing, or worsening.

  23. Target Wound Assessment for Infection [ Time Frame: At 14 days, 30 days, 42 days and 90 days ]
    Wound Assessment for Infection will be performed to determine the clinical indication of the presence or absence of infection.

  24. Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At baseline,1 month, 3 months, 6 months, 1 year and annually through 5 years ]

    The Rutherford Becker scale is a classification system for claudication and limb ischemia.

    Categories and Clinical Description:

    Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

    1. Lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm by investigator visual assessment.
    2. A total target lesion length of up to 100 mm.
    3. A maximum of 3 scaffolds can be implanted at the target lesion
    4. The total scaffold length among all target lesions must not exceed 170 mm (total everolimus drug dose of 1790 µg).
    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 length of diseased segment is ≤ 100 mm.
  2. 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.
  3. 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).
  4. 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
  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.

Exclusion Criteria:

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 type of amputation to the ipsilateral extremity, or a contralateral extremity amputation 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 ≥ 2.
  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 with serum albumin < 3 g/dL
  13. 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.
  14. 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.
  15. Subject has Body Mass Index (BMI) <18.
  16. Subject is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure.
  17. Subject has coagulation disorder.
  18. Subject who requires thrombolysis as a primary treatment modality or requires other treatment for acute limb ischemia of the target limb.
  19. Subject has previously had, or requires surgical revascularization involving any vessel of the ipsilateral extremity.
  20. Subject has systemic or limb infection, until treated successfully.
  21. Subject is bedridden or unable to walk (with assistance is acceptable).
  22. Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations. This includes subjects with:

    1. Osteomyelitis including and/or proximal to the metatarsal head
    2. Gangrene involving the plantar skin of the forefoot, midfoot, or heel
    3. Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel
    4. Full thickness heel ulcer with/without calcaneal involvement
    5. Any wound with calcaneal bone involvement
    6. Wounds that are deemed to be neuropathic or non-ischemic in nature
    7. Wounds that would require flap coverage or complex wound management for large soft tissue defect
    8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone.
  23. Subject is unable or unwilling to provide written consent prior to enrollment
  24. 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. Retrograde crossing of the guidewire.
  2. Lesions with severe calcification, in which there is a high likelihood that successful pre-dilatation cannot be achieved.
  3. Lesion that has prior metallic stent implant.
  4. 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.
  5. Inflow lesions or non-target infrapopliteal lesions that were treated using paclitaxel coated or eluting stents or DCB, during the index procedure.
  6. 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.
  7. Target or (if applicable) non-target vessel contains visible thrombus as indicated in the angiographic images.
  8. 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.)
  9. Target lesion can only be accessed via retrograde or pedal approach.
  10. Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
  11. No angiographic evidence of a patent pedal artery.
  12. 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).
  13. Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity.
  14. Visual assessment of the target lesion suggests that the investigator is unable to pre-dilate the lesion according to the vessel diameter.
  15. Target lesion has a high probability that atherectomy will be required at the time of index procedure for treatment of the target vessel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227899


Contacts
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Contact: Rhonda Hensley +1 (828) 527-9054 rhonda.hensley@abbott.com
Contact: Karine S Ruster, PhD +1 (408) 845-0764 karine.piard-ruster@abbott.com

Locations
Show Show 45 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Ramon L Varcoe, MBBS, MS, FRACS, PhD Prince of Wales Private Hospital, Randwick, NSW, Australia
Principal Investigator: Sahil Parikh, MD, FACC, FSCAI New York Presbyterian Hospital, New York, NY
Principal Investigator: Brian DeRubertis, MD, FACS University of California, Los Angeles, CA
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04227899    
Other Study ID Numbers: ABT-CIP-10293
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Abbott Medical Devices:
Infrapopliteal lesions
ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System
Percutaneous transluminal angioplasty (PTA)
ABT-CIP-10293
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes