Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis (DEB)

January 18, 2021 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)

The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In Canada, there are over 20,000 patients with chronic end-stage renal disease (ESRD)on long-term hemodialysis and the number is increasing rapidly.The creation of hemodialysis access (HA) (also called "lifeline" for dialysis patients) has become the most common type of vascular surgery. These HA are frequently complicated by dysfunction after their creation mainly due to neointimal hyperplastic stenosis (> 60% at one year). PTA is an established cornerstone method of treating stenotic lesions because of its minimally invasive percutaneous nature and widespread availability.Although PTA has a high initial success rate,narrowing will often recur in 2-3 months hence requiring further interventions. There are currently no durable therapies for the prevention or treatment of HA dysfunction restenosis after PTA.

Recently drug eluting balloon (DEB) with paclitaxel have repeatedly demonstrated their effectiveness to prevent restenosis due to intimal proliferation in the coronary and peripheral arterial systems. The investigators believe that the DEB with paclitaxel will significantly decrease the HA restenosis rate at the treated site and therefore will improve the management of HA failures.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Longueuil, Quebec, Canada
        • Hôpital Charles-LeMoyne
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Université de Montréal-CHUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical or hemodynamic evidence of HA dysfunction according to the clinician's judgment
  • Patients with AVF (arteriovenous fistulae)or AVG (arteriovenous graft) located in the forearm or upper arm and is > 3 months old
  • Minimum age of 18 years and written informed consent
  • Target lesion stenosis is <3.0 cm in length and >50% in luminal diameter reduction
  • Maximum of two secondary lesions (stenoses) if the following criteria are satisfied: The secondary lesion is located in the graft or peripheral veins, the secondary lesion is <3.0 cm in length and located >1.0 cm away from the target lesion, the secondary lesion is >50% luminal reduction compared to the reference vessel diameter
  • Reference vessel diameter between 4 to 7 mm
  • The HA must not be thrombosed and the lesion can be crossed with guide wire before angioplasty
  • Lesion site: from 2 cm above the arterial anastomosis to the superior vena cava
  • Restenotic lesion (previously treated by PTA or stent) or de novo lesion

Exclusion Criteria:

  • Contraindication to angiography or PTA
  • Intervention of the HA circuit within the past 30 days
  • Systemic infection or a local infection associated with the graft
  • The patient is pregnant
  • Patient is enrolled in another investigational study.
  • Life expectancy < 12 months
  • History of severe allergic reaction to contrast media or to paclitaxel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel Eluting Balloon
Paclitaxel Eluting Balloon Angioplasty
Device: Paclitaxel Eluting Balloon Angioplasty
Other Names:
  • Passeo-18 Lux
Active Comparator: Conventional uncoated balloon
Percutaneous Transluminal Angioplasty (PTA)
Device: Percutaneous Transluminal Angioplasty (PTA)
Other Names:
  • Passeo-18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty)
Time Frame: 6 months

Comparison of the mean LLL (late lumen loss) in patients in the two trial arms (DEB vs plain PTA) evaluated by quantitative angiography at six months after PTA.

LLL is defined as the difference between the MLD (minimum lumen diameter) immediately after balloon angioplasty and the MLD at follow-up
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The angiographic percentage of diameter stenosis and the incidence of angiographic binary restenosis rate (≥50% of the diameter of the reference-vessel segment)
Time Frame: 6 months
The change in the degree of stenosis (in %) at the intervention site between the measure right after the intervention, and 6 months later and the difference between restenosis rates in the two trial arms at 6 months.
6 months
Change of HA flow
Time Frame: Before angioplasty, week 1, month 1or month 3
Difference between mean HA flow in the two groups (measured at the same times)
Before angioplasty, week 1, month 1or month 3
The rate of HA failure
Time Frame: 3 months
Time elapsed from the initial intervention (at randomization) to the earliest (if any) of these 3 events: HA thrombosis, HA re-intervention (surgical or endovascular, including creation of a new HA), or CVC (central venous catheter) insertion for dialysis purpose
3 months
Drug eluting balloon safety
Time Frame: 3 months
Proportion of patients with side effects in the 2 groups.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Biotronik Canada Inc

Investigators

  • Principal Investigator: Éric Therasse, MD, Centre Hospitalier de l'Université de Montréal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

January 13, 2020

Study Completion (Actual)

August 27, 2020

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 26, 2013

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE13.093 (2014-5032)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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