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The ABSORB Bioresorbable Scaffold Below the Knee (BTK) Study

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ClinicalTrials.gov Identifier: NCT02793349
Recruitment Status : Terminated (Company have withdrawn the product)
First Posted : June 8, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ramon Varcoe, The University of New South Wales

Brief Summary:
ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a bioresorbable drug eluting stent in the arterial vasculature below the knee

Condition or disease Intervention/treatment Phase
Ischemia Peripheral Arterial Disease (PTA Arterial Occlusive Diseases Device: Absorb Bioresorbable Vascular Scaffold Not Applicable

Detailed Description:

The aim of this study is to evaluate the performance of a bioresorbable vascular scaffold (BVS) coated with the drug Everolimus. This will be used to treat short length blockages of up to 55mm (5.5cm) in arteries below the knee.

This will be performed to treat patients who have severe leg pain or have developed skin ulcers or gangrene which are not healing due to insufficent blood supply. The ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold works on similar principles of drug eluting stents which have been used for a considerable time in treating blocked arteries. However this product consists of a scaffold coated with a drug so rather than leaving a metallic stent in the blood vessel, this product primarily delivers the drug, gives mechanical support to the blood vessel and once it is no longer needed the scaffold absorbs into the body leaving no permanent metallic implant.

This same device has been used safely and effectively in the arteries which supply the heart both in clinical trials and current practice and has also been evaluated in the leg arteries in a single-centre pilot study. This study aims to evaluate it's use in a larger number of patients in multiple centres and compare that to a historical control group of metal drug eluting stents. The study will evaluate both ultrasound and angiographic derived patency in those arteries out to a 36 month follow-up time point. This data will be collected in patients who fulfill the inclusion criteria and who are then treated and followed over time.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ABSORB BTK Study: A Prospective, Multi-center, Controlled Clinical Evaluation of the Use of a Bioresorbable Drug Eluting Stent (Absorb, Abbott Vascular) in the Arterial Vasculature Below the Knee
Study Start Date : June 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Bioresorbable Vascular Scaffold
Absorb Bioresorbable Vascular Scaffold
Device: Absorb Bioresorbable Vascular Scaffold
Absorb Bioresorbable Vascular Scaffold
Other Name: BVS




Primary Outcome Measures :
  1. Angiographic patency [ Time Frame: 12 months ]
    Freedom from angiographic binary in-scaffold restenosis (>50% stenosis)


Secondary Outcome Measures :
  1. Technical success [ Time Frame: Procedure ]
    Technical success defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging.

  2. Haemodynamic primary, assisted primary and secondary patency [ Time Frame: 1 month ]
    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

  3. Haemodynamic primary, assisted primary and secondary patency [ Time Frame: 6 months ]
    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

  4. Haemodynamic primary, assisted primary and secondary patency [ Time Frame: 12 months ]
    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

  5. Haemodynamic primary, assisted primary and secondary patency [ Time Frame: 24 months ]
    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

  6. Haemodynamic primary, assisted primary and secondary patency [ Time Frame: 36 months ]
    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

  7. Limb salvage rate (LSR) [ Time Frame: 12 months ]
    Limb salvage defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)

  8. Target lesion revascularization (TLR) [ Time Frame: 12 months ]
    Target lesion revascularization (TLR) is defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge

  9. Rutherford Category [ Time Frame: 12 months ]
    Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification

  10. Adverse clinical events [ Time Frame: 12 months ]
    Clinical events defined as fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stenotic (> 50%) or occlusive atherosclerotic disease of the distal popliteal or infrapopliteal arteries
  • A maximum of two focal target lesions in one or more distal popliteal or infrapopliteal vessels
  • Length of lesion is maximally 55 mm, allowing maximally 2 stents to be implanted
  • Reference vessel diameter should be 2.5 mm-4 mm
  • Symptomatic critical limb ischemia (Rutherford 3, 4, 5)
  • Subject is able to take at least one type of thienopyridine (e.g. clopidogrel) and acetylsalicylic acid
  • The patient must be > 18 years of age
  • Life-expectancy of more than 12 months
  • The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
  • The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
  • The patient must provide written patient informed consent that is approved by the ethics committee

Exclusion Criteria:

  • Patient refusing treatment
  • The reference segment diameter is not suitable for available stent design.
  • Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis
  • Untreatable lesion located at the distal outflow arteries
  • More than two infrapopliteal lesions in the same limb
  • Previously implanted stent(s) or PTA at the same lesion site
  • Lesion location requiring kissing stent procedure
  • Lesion lies within or adjacent to an aneurysm
  • Inflow-limiting arterial lesions left untreated
  • The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
  • The patient takes Phenprocoumon (Marcumar).
  • The patient has a history of prior life-threatening contrast media reaction.
  • The patient is currently enrolled in another investigational device or drug trial.
  • The patient is currently breast-feeding, pregnant or intends to become pregnant.
  • The patient is mentally ill or retarded.
  • Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  • Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days 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.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (Cytochrome P450 3A4) (such as Rifampin) within 90 days following the procedure.
  • Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
  • Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure

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): NCT02793349


Locations
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Australia, New South Wales
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Australia, Victoria
Epworth Hospital
Melbourne, Victoria, Australia, 3121
Netherlands
Reinier de Graf Hospital
Delft, Netherlands, 2625AD
New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
The University of New South Wales
Investigators
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Principal Investigator: Ramon L Varcoe, MS,FRACS,PhD Prince of Wales Hospital

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Responsible Party: Ramon Varcoe, Principal Investigator, The University of New South Wales
ClinicalTrials.gov Identifier: NCT02793349     History of Changes
Other Study ID Numbers: HREC 15/051
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ramon Varcoe, The University of New South Wales:
angioplasty
stents
polymers
absorbable implants
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases