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Stenosis of Arteriovenous Dialysis FistulaDEBAPTANCT01544907

Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses

A study testing Conventional PTA and Drug Eluting Balloon (DEB) in people with Stenosis of Arteriovenous Dialysis Fistula and Arteriovenous Graft Stenosis, run by Singapore General Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty versus conventional percutaneous transluminal angioplasty balloon for the treatment of hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal loss and restenosis rates, while prolonging… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Conventional PTA and Drug Eluting Balloon (DEB)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteSingapore
Study dates
Jan 2012to Nov 2013
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Upper limb or groin AVF/AVG
  • The AVF/AVG is > 3 months old.
  • Native vessel measures between 4 to 7 mm diameter (corresponding to the sizes of available DEBs).
  • The fistula or graft must not be thrombosed.
  • Able to cross with guide wire
  • Platelet count >50,000/l (platelet infusion if <100,000/l)
  • PT/PTT not more than 3 seconds above normal (FFP infusion for abnormal PT/PTT)

Who cannot join

  • Uncorrectable coagulopathy (despite transfusion) or hypercoagulable state.
  • Evidence of systemic infection or a local infection associated with the fistula or graft.
  • The patient is < 21 years of age.
  • The patient is pregnant.
  • Patient is enrolled in another investigational study
  • Patient has comorbid conditions that may limit their ability to comply with the follow-up requirement.
  • Life expectancy < 6 months

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Singapore General Hospital

    Singapore, 169068

Other trials in Singapore

About this study

Official title: Prospective Randomized Trial Comparing Drug Eluting Balloon Angioplasty Versus Conventional Percutaneous Transluminal Angioplasty Balloon for the Treatment of Hemodialysis Arterio-Venous Fistula or Arterio-Venous Graft Stenoses

A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty versus conventional percutaneous transluminal angioplasty balloon for the treatment of hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.

Read the detailed description

Introduction:

Neointimal hyperplasia is the main cause of hemodialysis access [arterio-venous fistula (AVF) or graft (AVG)] dysfunction and thrombosis. Although endovascular techniques like percutaneous transluminal angioplasty (PTA), catheter directed thrombolysis, mechanical thrombectomy or bare metal stenting, may salvage the access, long term patency remains dismal due to recurrent stenosis from neointimal hyperplasia.

Drug Eluting Balloon (DEB) is effective in inhibiting neointimal hyperplasia for treatment of coronary in-stent restenosis since 2006 and more recently in femoropopliteal arteries, reducing restenosis rates and prolonging patency.

Specific Aim:

To determine the efficacy of DEB in reducing restenosis rates and prolonging the patency of AVFs/AVGs compared to PTA.

Hypothesis:

DEB is superior to PTA in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.

Methodology:

Prospective, randomized clinical trial with study population comprising of patients with dysfunctional AVFs/AVGs due to underlying stenoses. The patients will be randomized to receive either DEB or PTA.

The 6-month late luminal loss will be primary endpoint. The secondary endpoints of restenosis rate, primary and secondary patencies, will also be determined.

Major Clinical Significance:

Hemodialysis access failures constitute significant morbidity and costs to patient and healthcare system. Maintaining access patency consumes significant resources and constitutes a significant portion of the work of vascular surgeons, nephrologists and interventional radiologists.

Any strategy that reduces access failure or prolonging access lifespan will be beneficial. If DEB is proven to be superior to PTA, there will be a paradigm shift in management of hemodialysis access failures from restenosis - similar to how DEB has changed practice in managing coronary artery in-stent restenosis.

Being tested
Conventional PTA, Drug Eluting Balloon (DEB)
Keywords
Drug Eluting Balloon, Arteriovenous fistula or graft stenosis
Medical subject headings
Arteriovenous Fistula

What participants receive

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

  • Conventional PTADevice

    Also called REEF angioplasty balloon (Manufacturer Medtronic)

    Use of conventional balloon for angioplasty only

  • Drug Eluting Balloon (DEB)Device

    Also called IN.PACT ADMIRAL Paclitaxel-eluting Balloon (Medtronic)

    Use of DEB after conventional balloon angioplasty

Study groups in NCT01544907
Study groupRoleWhat they receive
Conventional PTA onlyActive comparatorTreatment Arm 1- Conventional PTA only The conventional balloon is used and the diameter of the balloon should be the same or oversized by 1mm the diameter of the reference vessel. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 2 minutes. At the end of the first angioplasty, an AVFistulogram/AVGraftogram will be obtained to document results. If there is residual stenosis of >30%, a repeat angioplasty using the same balloon or another appropriately oversized balloon by 1mm will be used for an additional 2 minutes. A final angiogram will be obtained for documentation.
Receives: Device: Conventional PTA
Drug Eluting Balloon (DEB)ExperimentalTreatment arm 2 - Conventional Balloon with DEB A Conventional balloon is used to pre-dilate the target lesion. The DEB of a similar diameter to the conventional balloon used is then inflated across the stenosis. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 1 minute. A final angiogram will be obtained for documentation. The drug coated on the DEB is Paclitaxel.
Receives: Device: Drug Eluting Balloon (DEB)

What is being measured

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

  1. Late luminal loss

    Late luminal loss is defined as the difference between the minimum lumen diameters after angioplasty and at the end of the 6-month follow-up angiogram.

    Measured: 6 months

Secondary outcomes (7)

  1. Restenosis rate

    Restenosis rate is defined as the incidence of stenosis ≥50% of the diameter of the reference vessel segment.

    Measured: 6 months

  2. Primary patency

    Primary patency is defined as the interval from balloon angioplasty until the next access thrombosis or repeated intervention to maintain access function, or until access abandonment if no interval intervention. It ends with treatment of a lesion anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction.

    Measured: 6 months

  3. Primary assisted patency

    Primary assisted patency is defined as the interval from balloon angioplasty until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit. Examples include percutaneous treatments of either restenosis/occlusion of the previously treated lesion or a new arterial or venous outflow stenosis/occlusion (excluding access thrombosis). It ends with percutaneous thrombolysis/thrombectomy or simple surgical thrombectomy.

    Measured: 6 months

  4. Secondary patency

    Secondary patency is defined as the interval after balloon angioplasty until the access is surgically declotted, revised or abandoned because of inability to treat the original lesion, choice of surgeon, transplant, loss to follow-up, etc. Examples include thrombolysis and percutaneous thrombectomy, as well as multiple repetitive treatments.

    Measured: 6 months

  5. Anatomic success

    Anatomic success is defined as <30% residual stenosis diameter measured immediately after angioplasty.

    Measured: Immediate post procedure

  6. Clinical success

    Clinical success is defined as an improvement from baseline in the clinical or hemodynamic parameter (e.g., blood flow, venous pressures) that was the initial indicator of fistula/ graft dysfunction.

    Measured: Immediate post procedure

  7. Procedural success

    Procedural success is defined as the combination of anatomic success and clinical success.

    Measured: Immediate post procedure

Timeline

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

  1. First posted6 Mar 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544907
Sponsor's protocol ID
DEBAPTA
Acronym
DEBAPTA
Status last verified
Nov 2017
First submitted
29 Feb 2012
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Conventional PTA and Drug Eluting Balloon (DEB) in people with Stenosis of Arteriovenous Dialysis Fistula and Arteriovenous Graft Stenosis, run by Singapore General Hospital at 1 site in Singapore.

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 7 inclusion and 7 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: finished, as of the sponsor's last update on 6 Nov 2017. 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 Singapore. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Late luminal loss (time frame: 6 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 NCT01544907.

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 6 Nov 2017.

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