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AtherosclerosisNCT01341340

The ABSORB BTK (Below The Knee) Clinical Investigation

A study testing Everolimus Eluting BVS in people with Atherosclerosis and Peripheral Artery Disease, run by Abbott Medical Devices at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Everolimus Eluting BVS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteBelgium
Study dates
Nov 2011to Nov 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be at least 18 and ≤ 80 years of age.
  • History of symptomatic critical limb ischemia (CLI) (Rutherford Becker Clinical Category 4 or 5).
  • Subject is able to take at least one type of thienopyridine (e.g. clopidogrel) and acetylsalicylic acid (eg. Aspirin/ASA).
  • The subject must have a life-expectancy of more than 1 year.
  • 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.
  • 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.
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  • Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
  • 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
  • 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.
  • Target lesion length is visually estimated to be ≤ 24 mm.
  • 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.
  • 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.
  • 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.]
  • 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.
  • 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.
  • 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.
  • Patent pedal outflow artery (< 50% stenosis) that will provide a straight line of blood flow to the distal foot and (if applicable) wound area.

Who cannot join

  • Subject is unable to understand or unwilling to cooperate with study procedures.
  • The subject is mentally ill or belongs to a vulnerable population.
  • Subject is currently breast-feeding, pregnant, or intends to become pregnant prior to completion of the 1 year angiographic follow-up.
  • Subject has had any type of amputation to the ipsilateral or contralateral extremity.
  • Subject is unable to walk. (with assistance is accepted)
  • Subject has had recent major surgery (requiring general or regional anesthesia or impacting major organ systems) within the last 3 months.
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  • Subject has received, or is on the waiting list for a major organ transplant.
  • Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 2, 3 or 6.
  • Subject has any type of infection, until treated successfully.
  • Subject has osteomyelitis present in the distal ipsilateral extremity.
  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • The subject has a history of prior life-threatening contrast media reaction.
  • Subject is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure.
  • 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.).
  • Subject is receiving or will receive inhibitors of CYP3A or inducers of CYP3A within 30 days prior to or following the procedure.
  • Subject is receiving Phenprocoumon (Marcumar) or is scheduled to receive chronic anticoagulation therapy.
  • 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).
  • 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.
  • Subject has elevated serum creatinine > 2.0 mg/dl or > 150μmol/L.
  • Subject has uncontrolled diabetes mellitus (DM) (glucose > 400 mg/dl).
  • Subject has had a myocardial infarction (MI) within the previous 30 days or has unstable angina (defined as rest angina with ECG changes).
  • Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subject's mobility.
  • Subject has acute thrombophlebitis or deep vein thrombosis in either extremity
  • 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.
  • 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.
  • 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).
  • Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
  • Anatomic Exclusion Criteria
  • The target lesion can only be accessed via popliteal or pedal approach.
  • The target vessel diameter at the location of the target lesion is not suitable for available BVS size.
  • Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
  • No angiographic evidence of a patent pedal artery.
  • Significant (> 50% stenosis) lesion in a distal outflow artery that requires treatment at the time of the index procedure.
  • More than a single significant lesion (> 50% stenosis) in the target vessel.
  • Target or (if applicable) non-target lesion location requiring bifurcation treatment method.
  • Target or (if applicable) non-target lesion lies within or adjacent to an aneurysm.
  • 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.
  • Subject has previously had, or requires, bypass surgery, endarterectomy or other vascular surgery on any vessel of the ipsilateral extremity.
  • 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.
  • Target or (if applicable) non-target vessel contains visible thrombus as indicated in the angiographic images.
  • 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.)
  • 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.).
  • Subject has lesions in the target vessel that were treated or will require treatment < 1 year pre-or post- study procedure.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Abbott Vascular International Bvba

    Diegem

Other trials in Belgium

About this study

Official title: A Clinical Evaluation of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) for the Treatment of Subjects With Critical Limb Ischemia (CLI) From Occlusive Vascular Disease of the Tibial Arteries

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.

Being tested
Everolimus Eluting BVS
Keywords
Stent, Infrapopliteal, Tibial, Limb Salvage
Medical subject headings
Atherosclerosis, Peripheral Arterial Disease, Peripheral Vascular Diseases, Intermittent Claudication, Chronic Limb-Threatening Ischemia, Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Everolimus Eluting BVSDevice

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

Study groups in NCT01341340
Study groupRoleWhat they receive
Everolimus Eluting BVSExperimentalPatients receiving the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS)
Receives: Device: Everolimus Eluting BVS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (108)

  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.

    Measured: 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%.

    Measured: 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.

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

  4. Death

    all cause

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

  5. Death

    all cause.

    Measured: 1 month

  6. Death

    all cause.

    Measured: 6 months

  7. Death

    all cause.

    Measured: 1 year

  8. Death

    all cause.

    Measured: 2 years

  9. Death

    all cause.

    Measured: 3 years

  10. Amputations

    minor and major

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

  11. Amputations

    minor and major

    Measured: 1 month

  12. Amputations

    minor and major

    Measured: 6 months

  13. Amputations

    minor and major

    Measured: 1 year

  14. Amputations

    minor and major

    Measured: 2 years

  15. Amputations

    minor and major

    Measured: 3 years

  16. Limb Salvage

    Freedom from ipsilateral major amputations

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

  17. Limb Salvage

    Freedom from ipsilateral major amputations

    Measured: 1 month

  18. Limb Salvage

    Freedom from ipsilateral major amputations

    Measured: 6 months

  19. Limb Salvage

    Freedom from ipsilateral major amputations

    Measured: 1 year

  20. Limb Salvage

    Freedom from ipsilateral major amputations

    Measured: 2 years

  21. Limb Salvage

    Freedom from ipsilateral major amputations

    Measured: 3 years

  22. Arterial thrombosis of the BVS

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

  23. Arterial thrombosis of the BVS

    Measured: 1 month

  24. Arterial thrombosis of the BVS

    Measured: 6 months

  25. Arterial thrombosis of the BVS

    Measured: 1 year

  26. Arterial thrombosis of the BVS

    Measured: 2 years

  27. Arterial thrombosis of the BVS

    Measured: 3 years

  28. Amputation-free survival (AFS)

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

  29. Amputation-free survival (AFS)

    Measured: 1 month

  30. Amputation-free survival (AFS)

    Measured: 6 months

  31. Amputation-free survival (AFS)

    Measured: 1 year

  32. Amputation-free survival (AFS)

    Measured: 2 years

  33. Amputation-free survival (AFS)

    Measured: 3 years

  34. Ipsilateral embolic events

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

  35. Ipsilateral embolic events

    Measured: 1 month

  36. Ipsilateral embolic events

    Measured: 6 months

  37. Ipsilateral embolic events

    Measured: 1 year

  38. Ipsilateral embolic events

    Measured: 2 years

  39. Ipsilateral embolic events

    Measured: 3 years

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

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

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

    Measured: 1 month

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

    Measured: 6 months

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

    Measured: 1 years

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

    Measured: 2 years

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

    Measured: 3 years

  46. Ipsilateral extremity revascularization (IER)

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

  47. Ipsilateral extremity revascularization (IER)

    Measured: 1 month

  48. Ipsilateral extremity revascularization (IER)

    Measured: 6 months

  49. Ipsilateral extremity revascularization (IER)

    Measured: 1 year

  50. Ipsilateral extremity revascularization (IER)

    Measured: 2 years

  51. Ipsilateral extremity revascularization (IER)

    Measured: 3 years

  52. Peak Systolic Velocity Ratio (PSVR)

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

  53. Peak Systolic Velocity Ratio (PSVR)

    Measured: 1 month

  54. Peak Systolic Velocity Ratio (PSVR)

    Measured: 6 months

  55. Peak Systolic Velocity Ratio (PSVR)

    Measured: 1 year

  56. Peak Systolic Velocity Ratio (PSVR)

    Measured: 2 years

  57. Peak Systolic Velocity Ratio (PSVR)

    Measured: 3 years

  58. Primary patency rate

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

  59. Primary patency rate

    Measured: 1 month

  60. Primary patency rate

    Measured: 6 months

  61. Primary patency rate

    Measured: 1 year

  62. Primary patency rate

    Measured: 2 years

  63. Primary patency rate

    Measured: 3 years

  64. Secondary patency rate

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

  65. Secondary patency rate

    Measured: 1 month

  66. Secondary patency rate

    Measured: 6 months

  67. Secondary patency rate

    Measured: 1 year

  68. Secondary patency rate

    Measured: 2 years

  69. Secondary patency rate

    Measured: 3 years

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

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

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

    Measured: 1 month

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

    Measured: 6 months

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

    Measured: 1 year

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

    Measured: 2 years

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

    Measured: 3 years

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

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

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

    Measured: 1 month

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

    Measured: 6 months

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

    Measured: 1 year

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

    Measured: 2 years

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

    Measured: 3 years

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

    Measured: 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

    Measured: 1 month

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

    Measured: 6 months

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

    Measured: 1 year

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

    Measured: 2 years

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

    Measured: 3 years

  88. Walking capacity and change from baseline

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

  89. Walking capacity and change from baseline

    Measured: 1 month

  90. Walking capacity and change from baseline

    Measured: 6 months

  91. Walking capacity and change from baseline

    Measured: 1 year

  92. Walking capacity and change from baseline

    Measured: 2 years

  93. Walking capacity and change from baseline

    Measured: 3 years

  94. Quality of Life Measures and change from baseline

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

  95. Quality of Life Measures and change from baseline

    Measured: 1 month

  96. Quality of Life Measures and change from baseline

    Measured: 6 months

  97. Quality of Life Measures and change from baseline

    Measured: 1 year

  98. Quality of Life Measures and change from baseline

    Measured: 2 years

  99. Quality of Life Measures and change from baseline

    Measured: 3 years

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

    Measured: 1 year

  101. Target lesion mean treated site late loss

    Measured: 1 year

  102. Target lesion treated site binary restenosis

    Measured: 1 year

  103. Treated site Peak Systolic Velocity (PSV)

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

  104. Treated site Peak Systolic Velocity (PSV)

    Measured: 1 month

  105. Treated site Peak Systolic Velocity (PSV)

    Measured: 6 months

  106. Treated site Peak Systolic Velocity (PSV)

    Measured: 1 year

  107. Treated site Peak Systolic Velocity (PSV)

    Measured: 2 years

  108. Treated site Peak Systolic Velocity (PSV)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Why it stopped: Discontinued due to poor enrollment. Insufficient number of patients enrolled to permit a statistically rigorous assessment of safety and efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01341340
Sponsor's protocol ID
10-112
Status last verified
Apr 2019
First submitted
15 Apr 2011
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Everolimus Eluting BVS in people with Atherosclerosis and Peripheral Artery Disease, run by Abbott Medical Devices at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Discontinued due to poor enrollment. Insufficient number of patients enrolled to permit a statistically rigorous assessment of safety and efficacy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from major adverse limb events (MALE) within 1 year or peri-procedural (30-day) death (POD) (MALE+POD). (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01341340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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