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IschemiaNCT02793349

The ABSORB Bioresorbable Scaffold Below the Knee (BTK) Study

A study testing Absorb Bioresorbable Vascular Scaffold in people with Ischemia and Peripheral Arterial Disease (PTA, run by The University of New South Wales at 4 sites in 3 countries.

Terminated

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

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Absorb Bioresorbable Vascular Scaffold
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
4 sitesin 3 countries
Study dates
Jun 2015to Jun 2017
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Australia2 sites

  • Epworth Hospital

    Melbourne, Victoria, 3121

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031

Other trials in Australia

Netherlands1 site

  • Reinier de Graf Hospital

    Delft, 2625AD

Other trials in Netherlands

New Zealand1 site

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

About this study

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

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

Read the 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.

Being tested
Absorb Bioresorbable Vascular Scaffold
Keywords
angioplasty, stents, polymers, absorbable implants
Medical subject headings
Ischemia, Peripheral Arterial Disease, Truncus Arteriosus, Persistent, Arterial Occlusive Diseases

What participants receive

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

  • Absorb Bioresorbable Vascular ScaffoldDevice

    Also called BVS

    Absorb Bioresorbable Vascular Scaffold

Study groups in NCT02793349
Study groupRoleWhat they receive
Bioresorbable Vascular ScaffoldExperimentalAbsorb Bioresorbable Vascular Scaffold
Receives: Device: Absorb Bioresorbable Vascular Scaffold

What is being measured

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

  1. Angiographic patency

    Freedom from angiographic binary in-scaffold restenosis (>50% stenosis)

    Measured: 12 months

Secondary outcomes (10)

  1. Technical success

    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.

    Measured: Procedure

  2. Haemodynamic primary, assisted primary and secondary patency

    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

    Measured: 1 month

  3. Haemodynamic primary, assisted primary and secondary patency

    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

    Measured: 6 months

  4. Haemodynamic primary, assisted primary and secondary patency

    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

    Measured: 12 months

  5. Haemodynamic primary, assisted primary and secondary patency

    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

    Measured: 24 months

  6. Haemodynamic primary, assisted primary and secondary patency

    Haemodynamic primary, assisted primary and secondary patency as assessed by ultrasound

    Measured: 36 months

  7. Limb salvage rate (LSR)

    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)

    Measured: 12 months

  8. Target lesion revascularization (TLR)

    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

    Measured: 12 months

  9. Rutherford Category

    Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification

    Measured: 12 months

  10. Adverse clinical events

    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

    Measured: 12 months

Timeline

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

  1. First posted8 Jun 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2017
  4. Study completionJun 2017

Why it stopped: Company have withdrawn the product

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02793349
Sponsor's protocol ID
HREC 15/051
Status last verified
Apr 2019
First submitted
3 Jun 2016
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Absorb Bioresorbable Vascular Scaffold in people with Ischemia and Peripheral Arterial Disease (PTA, run by The University of New South Wales at 4 sites in 3 countries.

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 11 inclusion and 20 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 17 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 4 sites in Australia, Netherlands, New Zealand. 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: Company have withdrawn the product). 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?

Angiographic patency (time frame: 12 months). 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 NCT02793349.

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 17 Apr 2019.

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