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DialysisPhase 2/3NCT01174472

Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

A Phase 2/3 study testing Percutaneous Transluminal Angioplasty (PTA) in people with Dialysis and Angioplasty, run by University of Patras at 1 site in Greece.

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

The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Dialysis, Angioplasty
What is being tested?
Percutaneous Transluminal Angioplasty (PTA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGreece
Study dates
Mar 2010to Jan 2012
Phase
Phase 2/3
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Angiographic and clinical diagnosis of dysfunctional dialysis access due to one or more stenotic lesions.
  • Patients with AVF or AVG
  • Fistula or graft or vessel diameter ranging from 3 mm up to 12 mm

Who cannot join

  • Fistula or graft or vessel diameter < 3 mm and > 12 mm
  • History of severe allergic reaction to contrast media
  • Intolerance to aspirin and/or clopidogrel
  • Systemic coagulopathy or hypercoagulation disorders

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Patras University Hospital, Department of Radiology, Angiography Suite

    Rio, Achaias, 26504

Other trials in Greece

About this study

Official title: Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.

The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.

Read the detailed description

In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.

Being tested
Percutaneous Transluminal Angioplasty (PTA)
Keywords
Dialysis access, angioplasty, drug eluting balloon

What participants receive

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

  • Percutaneous Transluminal Angioplasty (PTA)Device

    Also called IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter

    Angioplasty performed with the use of the novel paclitaxel eluting balloons

  • Percutaneous Transluminal Angioplasty (PTA)Device

    Also called Conquest PTA Balloon Dilatation Catheter

    Angioplasty performed with the use of conventional angioplasty balloons

Study groups in NCT01174472
Study groupRoleWhat they receive
Conventional Balloon Angioplasty (COBA)Active comparatorPatients with lesions treated with conventional balloon angioplasty
Receives: Device: Percutaneous Transluminal Angioplasty (PTA)
Drug Eluting Balloon Angioplasty (DEB)ExperimentalPatients with lesions treated with Drug Balloon Angioplasty
Receives: Device: Percutaneous Transluminal Angioplasty (PTA)

What is being measured

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

  1. Technical success

    Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography

    Measured: 1 minute after the final balloon angioplasty

  2. Primary patency

    Angiographic visualization of a lesion with <50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access.

    Measured: 1 year

Secondary outcomes (4)

  1. Secondary patency

    Angiographicaly proven patency (<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access)of the treated lesion following one re-intervention procedure of any kind.

    Measured: 1 year

  2. Target lesion re-intervention (TLR)-free interval

    The time interval without any additional recanalization procedure within the area of the treated lesion, because of angiographic or/and clinical deterioration

    Measured: 1 year

  3. Major complications rates

    Classified according to published international guidelines and reporting standards

    Measured: Periprocedural and up to 1 year

  4. Minor complications rates

    Classified according to published international guidelines and reporting standards

    Measured: Periprocedural and up to 1 year follow-up

Timeline

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

  1. First posted3 Aug 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2010
  4. Study completionJan 2012

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01174472
Sponsor's protocol ID
9462/14-4-2010
Status last verified
Jan 2012
First submitted
21 Jul 2010
Last updated
23 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol. 2015 Mar;84(3):418-423. doi: 10.1016/j.ejrad.2014.11.037. Epub 2014 Dec 15.

    PubMed 25575743

  • Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1.

    PubMed 22545894

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Percutaneous Transluminal Angioplasty (PTA) in people with Dialysis and Angioplasty, run by University of Patras at 1 site in Greece.

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 3 inclusion and 4 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 23 Jan 2012. 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 Greece. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Technical success (time frame: 1 minute after the final balloon angioplasty). The study lists 2 primary outcomes in all. 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 NCT01174472, which also lists 2 linked publications.

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 23 Jan 2012.

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