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TerminatedNCT01341340Updated Apr 11, 2019

The ABSORB BTK (Below The Knee) Clinical Investigation

An interventional study of Everolimus Eluting BVS in Atherosclerosis, Peripheral Artery Disease and Peripheral Vascular Disease, sponsored by Abbott Medical Devices. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-11.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Why this study was terminated
Discontinued due to poor enrollment. Insufficient number of patients enrolled to permit a statistically rigorous assessment of safety and efficacy.
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.

02

Conditions studied

  • Atherosclerosis
  • Peripheral Artery Disease
  • Peripheral Vascular Disease
  • PAD
  • Claudication
  • Critical Limb Ischemia
  • Lower Limb Disease
  • Peripheral Arterial Occlusive Disease
  • PAOD
  • PVD

Keywords

  • Stent
  • Infrapopliteal
  • Tibial
  • Limb Salvage
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 2 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject must be at least 18 and ≤ 80 years of age.
  2. History of symptomatic critical limb ischemia (CLI) (Rutherford Becker Clinical Category 4 or 5).
  3. Subject is able to take at least one type of thienopyridine (e.g. clopidogrel) and acetylsalicylic acid (eg. Aspirin/ASA).
  4. The subject must have a life-expectancy of more than 1 year.
  5. Female subjects of childbearing potential must have had a negative pregnancy test within 14 days before treatment, must not be nursing at the time of treatment, and must also agree at time of consent to use birth control during participation in this study up to and including the angiographic follow-up at 1 year.
  6. Subject has been informed of the nature of the study, agrees to its provisions, and has signed the informed consent form prior to any study related procedure.
  7. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
  8. Subject must agree not to participate in any other clinical investigation for a period of one year following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.

Anatomic Inclusion Criteria

  1. Up to two de novo lesions, each located in a separate native infrapopliteal vessel, with angiographically visible above-the-ankle reconstitution (proximal to the inferior cortical margin of the talus bone), only one of which can be designated as the target lesion and is suitable to be treated with a single BVS.
  2. Target lesion length is visually estimated to be ≤ 24 mm.
  3. Target vessel diameter at the location of the target lesion is ≥ 2.5 mm and ≤ 3.3 mm, as assessed by on-line quantitative angiography as per core laboratory guidelines.
  4. The non-target lesion (if applicable) must be located in a separate infrapopliteal vessel, estimated to be ≤ 24 mm, and suitable to be treated with non-study percutaneous transluminal angioplasty (PTA) balloon(s) and/or a non-study stent.
  5. Inflow between the proximal iliac and distal popliteal is unobstructed (free from ≥ 50% stenosis) as confirmed by angiography. [Note: Assessment may be made after interventions proximal to the target lesion.]
  6. Subjects with a significant lesion (≥ 50% stenosis) in the inflow artery(ies) must have the inflow artery(ies) treated successfully prior to enrollment and treatment of the target lesion.
  7. If there is evidence of an ischemic lesion/ulcer on the foot, the distribution of the target vessel must supply the area of the lesion (angiosome), as confirmed by angiography.
  8. At least one patent distal tibial outflow artery (\< 50% stenosis) that will provide a straight line of blood flow to the distal foot and (if applicable) wound area after treating a target lesion in the tibio-peroneal trunk.
  9. Patent pedal outflow artery (\< 50% stenosis) that will provide a straight line of blood flow to the distal foot and (if applicable) wound area.

Exclusion criteria

Exclusion Criteria:

  1. Subject is unable to understand or unwilling to cooperate with study procedures.
  2. The subject is mentally ill or belongs to a vulnerable population.
  3. Subject is currently breast-feeding, pregnant, or intends to become pregnant prior to completion of the 1 year angiographic follow-up.
  4. Subject has had any type of amputation to the ipsilateral or contralateral extremity.
  5. Subject is unable to walk. (with assistance is accepted)
  6. Subject has had recent major surgery (requiring general or regional anesthesia or impacting major organ systems) within the last 3 months.
  7. Subject has received, or is on the waiting list for a major organ transplant.
  8. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 2, 3 or 6.
  9. Subject has any type of infection, until treated successfully.
  10. Subject has osteomyelitis present in the distal ipsilateral extremity.
  11. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  12. The subject has a history of prior life-threatening contrast media reaction.
  13. Subject is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure.
  14. Subject is receiving immunosuppression therapy, or 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.).
  15. Subject is receiving or will receive inhibitors of CYP3A or inducers of CYP3A within 30 days prior to or following the procedure.
  16. Subject is receiving Phenprocoumon (Marcumar) or is scheduled to receive chronic anticoagulation therapy.
  17. Subject has severe liver impairment as defined by total bilirubin > 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transminase(SGOT) or serum glutamic pyruvic transminase (SGPT).
  18. Subject has platelet count \< 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC \< 3,000 cells/mm3, or hemoglobin \< 10.0 g/dl.
  19. Subject has elevated serum creatinine > 2.0 mg/dl or > 150μmol/L.
  20. Subject has uncontrolled diabetes mellitus (DM) (glucose > 400 mg/dl).
  21. Subject has had a myocardial infarction (MI) within the previous 30 days or has unstable angina (defined as rest angina with ECG changes).
  22. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subject's mobility.
  23. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity
  24. Subject has known allergies to the following: aspirin, thienopyridines, heparin, contrast agent (that cannot be adequately treated with pre-medication or substitution for an alternate thienopyridine), poly (L-lactide), poly (DL-lactide), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus), or other macrolides.
  25. Subject requires any planned procedure that would necessitate the discontinuation of thienopyridines following the procedure. If the subject is enrolled into the study and then requires a medical procedure, which would necessitate the discontinuation of these medications, then the subject is to resume protocol recommended medications as soon as possible.
  26. Subject has other known medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 1 year).
  27. Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.

Anatomic Exclusion Criteria

  1. The target lesion can only be accessed via popliteal or pedal approach.
  2. The target vessel diameter at the location of the target lesion is not suitable for available BVS size.
  3. Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
  4. No angiographic evidence of a patent pedal artery.
  5. Significant (> 50% stenosis) lesion in a distal outflow artery that requires treatment at the time of the index procedure.
  6. More than a single significant lesion (> 50% stenosis) in the target vessel.
  7. Target or (if applicable) non-target lesion location requiring bifurcation treatment method.
  8. Target or (if applicable) non-target lesion lies within or adjacent to an aneurysm.
  9. A segment/portion of the study scaffold will be deployed distal to the inferior cortical margin of the talus bone or in a pedal vessel.
  10. Subject has previously had, or requires, bypass surgery, endarterectomy or other vascular surgery on any vessel of the ipsilateral extremity.
  11. Subject has moderate to severe calcium in the target lesion or in the artery immediately adjacent to the target lesion, or the investigator is unable to pre-dilate the lesion according to vessel diameter.
  12. Target or (if applicable) non-target vessel contains visible thrombus as indicated in the angiographic images.
  13. Subject has angiographic evidence of thromboembolism or atheroembolism in the ipsilateral extremity. (Pre and post-angiographic images must confirm the absence of emboli in the distal anatomy.)
  14. Target or (if applicable) non-target lesion has a high probability that a procedure other than pre-dilatation, implantation of the scaffold, and post-dilatation (as applicable) will be required at the time of index procedure for treatment of the target vessel (e.g., atherectomy, cutting balloon, etc.).
  15. Subject has lesions in the target vessel that were treated or will require treatment \< 1 year pre-or post- study procedure.
  16. Subject has lesions in any other vascular anatomy, other than those treated at the time of the study procedure, that were treated or will require treatment \< 30 days pre-or post- study procedure.
  17. Subject has had or will require treatment with a drug-eluting/coated stent or drugcoated balloon in any vessel \< 90 days pre-or post-study procedure.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Everolimus Eluting BVS

    Patients receiving the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS)

    Device: Everolimus Eluting BVS

Interventions

  • DeviceEverolimus Eluting BVS

    Patients receiving the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS)

06

What researchers measure

Primary outcomes

  1. Freedom from major adverse limb events (MALE) within 1 year or peri-procedural (30-day) death (POD) (MALE+POD).

    Major adverse limb events are defined as major amputations or major reinterventions. Major reinterventions include new bypass graft, jump/interposition graft revision, or thrombectomy /thrombolysis related to the target lesion, but do not include percutaneous endovascular reinterventions.

    Time frame: 1 year

Secondary outcomes

  1. Device Success

    On a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

    Time frame: From start of index procedure to end of index procedure

  2. Technical Success

    Defined on a per lesion basis, as the achievement of successful delivery and deployment of the study device(s) at the intended target lesion, successful withdrawal of the delivery catheter, and attainment of a final residual stenosis of \< 30%.

    Time frame: From start of index procedure to end of index procedure

  3. Clinical Success

    On a per subject basis, technical success without complications within 48 hours after the index procedure or at hospital discharge, whichever is sooner.

    Time frame: Within 48 hours after the index procedure or at hospital discharge, whichever is sooner

  4. Death

    all cause

    Time frame: From start of procedure until discharge from treating or referral hospital

  5. Death

    all cause.

    Time frame: 1 month

  6. Death

    all cause.

    Time frame: 6 months

  7. Death

    all cause.

    Time frame: 1 year

  8. Death

    all cause.

    Time frame: 2 years

  9. Death

    all cause.

    Time frame: 3 years

  10. Amputations

    minor and major

    Time frame: From start of procedure until discharge from treating or referral hospital

  11. Amputations

    minor and major

    Time frame: 1 month

  12. Amputations

    minor and major

    Time frame: 6 months

  13. Amputations

    minor and major

    Time frame: 1 year

  14. Amputations

    minor and major

    Time frame: 2 years

  15. Amputations

    minor and major

    Time frame: 3 years

  16. Limb Salvage

    Freedom from ipsilateral major amputations

    Time frame: From start of procedure until discharge from treating or referral hospital

  17. Limb Salvage

    Freedom from ipsilateral major amputations

    Time frame: 1 month

  18. Limb Salvage

    Freedom from ipsilateral major amputations

    Time frame: 6 months

  19. Limb Salvage

    Freedom from ipsilateral major amputations

    Time frame: 1 year

  20. Limb Salvage

    Freedom from ipsilateral major amputations

    Time frame: 2 years

  21. Limb Salvage

    Freedom from ipsilateral major amputations

    Time frame: 3 years

  22. Arterial thrombosis of the BVS

    Time frame: From start of procedure until discharge from treating or referral hospital

  23. Arterial thrombosis of the BVS

    Time frame: 1 month

  24. Arterial thrombosis of the BVS

    Time frame: 6 months

  25. Arterial thrombosis of the BVS

    Time frame: 1 year

  26. Arterial thrombosis of the BVS

    Time frame: 2 years

  27. Arterial thrombosis of the BVS

    Time frame: 3 years

  28. Amputation-free survival (AFS)

    Time frame: From start of procedure until discharge from treating or referral hospital

  29. Amputation-free survival (AFS)

    Time frame: 1 month

  30. Amputation-free survival (AFS)

    Time frame: 6 months

  31. Amputation-free survival (AFS)

    Time frame: 1 year

  32. Amputation-free survival (AFS)

    Time frame: 2 years

  33. Amputation-free survival (AFS)

    Time frame: 3 years

  34. Ipsilateral embolic events

    Time frame: From start of procedure until discharge from treating or referral hospital

  35. Ipsilateral embolic events

    Time frame: 1 month

  36. Ipsilateral embolic events

    Time frame: 6 months

  37. Ipsilateral embolic events

    Time frame: 1 year

  38. Ipsilateral embolic events

    Time frame: 2 years

  39. Ipsilateral embolic events

    Time frame: 3 years

  40. Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)

    Time frame: From start of procedure until discharge from treating or referral hospital

  41. Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)

    Time frame: 1 month

  42. Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)

    Time frame: 6 months

  43. Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)

    Time frame: 1 years

  44. Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)

    Time frame: 2 years

  45. Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)

    Time frame: 3 years

  46. Ipsilateral extremity revascularization (IER)

    Time frame: From start of procedure until discharge from treating or referral hospital

  47. Ipsilateral extremity revascularization (IER)

    Time frame: 1 month

  48. Ipsilateral extremity revascularization (IER)

    Time frame: 6 months

  49. Ipsilateral extremity revascularization (IER)

    Time frame: 1 year

  50. Ipsilateral extremity revascularization (IER)

    Time frame: 2 years

  51. Ipsilateral extremity revascularization (IER)

    Time frame: 3 years

  52. Peak Systolic Velocity Ratio (PSVR)

    Time frame: From start of procedure until discharge from treating or referral hospital

  53. Peak Systolic Velocity Ratio (PSVR)

    Time frame: 1 month

  54. Peak Systolic Velocity Ratio (PSVR)

    Time frame: 6 months

  55. Peak Systolic Velocity Ratio (PSVR)

    Time frame: 1 year

  56. Peak Systolic Velocity Ratio (PSVR)

    Time frame: 2 years

  57. Peak Systolic Velocity Ratio (PSVR)

    Time frame: 3 years

  58. Primary patency rate

    Time frame: From start of procedure until discharge from treating or referral hospital

  59. Primary patency rate

    Time frame: 1 month

  60. Primary patency rate

    Time frame: 6 months

  61. Primary patency rate

    Time frame: 1 year

  62. Primary patency rate

    Time frame: 2 years

  63. Primary patency rate

    Time frame: 3 years

  64. Secondary patency rate

    Time frame: From start of procedure until discharge from treating or referral hospital

  65. Secondary patency rate

    Time frame: 1 month

  66. Secondary patency rate

    Time frame: 6 months

  67. Secondary patency rate

    Time frame: 1 year

  68. Secondary patency rate

    Time frame: 2 years

  69. Secondary patency rate

    Time frame: 3 years

  70. Rutherford Becker clinical category and change from baseline for the treated limb

    Time frame: From start of procedure until discharge from treating or referral hospital

  71. Rutherford Becker clinical category and change from baseline for the treated limb

    Time frame: 1 month

  72. Rutherford Becker clinical category and change from baseline for the treated limb

    Time frame: 6 months

  73. Rutherford Becker clinical category and change from baseline for the treated limb

    Time frame: 1 year

  74. Rutherford Becker clinical category and change from baseline for the treated limb

    Time frame: 2 years

  75. Rutherford Becker clinical category and change from baseline for the treated limb

    Time frame: 3 years

  76. Ankle brachial index (ABI) and change from baseline for the treated limb

    Time frame: From start of procedure until discharge from treating or referral hospital

  77. Ankle brachial index (ABI) and change from baseline for the treated limb

    Time frame: 1 month

  78. Ankle brachial index (ABI) and change from baseline for the treated limb

    Time frame: 6 months

  79. Ankle brachial index (ABI) and change from baseline for the treated limb

    Time frame: 1 year

  80. Ankle brachial index (ABI) and change from baseline for the treated limb

    Time frame: 2 years

  81. Ankle brachial index (ABI) and change from baseline for the treated limb

    Time frame: 3 years

  82. Wound healing as measured by aggregate ulcer size and its change from baseline

    Time frame: From start of procedure until discharge from treating or referral hospital

  83. Wound healing as measured by aggregate ulcer size and its change from baseline

    Time frame: 1 month

  84. Wound healing as measured by aggregate ulcer size and its change from baseline

    Time frame: 6 months

  85. Wound healing as measured by aggregate ulcer size and its change from baseline

    Time frame: 1 year

  86. Wound healing as measured by aggregate ulcer size and its change from baseline

    Time frame: 2 years

  87. Wound healing as measured by aggregate ulcer size and its change from baseline

    Time frame: 3 years

  88. Walking capacity and change from baseline

    Time frame: From start of procedure until discharge from treating or referral hospital

  89. Walking capacity and change from baseline

    Time frame: 1 month

  90. Walking capacity and change from baseline

    Time frame: 6 months

  91. Walking capacity and change from baseline

    Time frame: 1 year

  92. Walking capacity and change from baseline

    Time frame: 2 years

  93. Walking capacity and change from baseline

    Time frame: 3 years

  94. Quality of Life Measures and change from baseline

    Time frame: From start of procedure until discharge from treating or referral hospital

  95. Quality of Life Measures and change from baseline

    Time frame: 1 month

  96. Quality of Life Measures and change from baseline

    Time frame: 6 months

  97. Quality of Life Measures and change from baseline

    Time frame: 1 year

  98. Quality of Life Measures and change from baseline

    Time frame: 2 years

  99. Quality of Life Measures and change from baseline

    Time frame: 3 years

  100. Target lesion mean and maximum treated site percent diameter stenosis (%DS)

    Time frame: 1 year

  101. Target lesion mean treated site late loss

    Time frame: 1 year

  102. Target lesion treated site binary restenosis

    Time frame: 1 year

  103. Treated site Peak Systolic Velocity (PSV)

    Time frame: From start of procedure until discharge from treating or referral hospital

  104. Treated site Peak Systolic Velocity (PSV)

    Time frame: 1 month

  105. Treated site Peak Systolic Velocity (PSV)

    Time frame: 6 months

  106. Treated site Peak Systolic Velocity (PSV)

    Time frame: 1 year

  107. Treated site Peak Systolic Velocity (PSV)

    Time frame: 2 years

  108. Treated site Peak Systolic Velocity (PSV)

    Time frame: 3 years

07

Study locations

1 site
  • Abbott Vascular International Bvba
    Diegem, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01341340
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Apr 25, 2011
Start date
Nov 2011
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Apr 11, 2019

Study contacts

Dierk Scheinert, MD
principal investigator · Herz-Zentrum Leipzig

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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