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

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ClinicalTrials.gov Identifier: NCT01928498
Recruitment Status : Active, not recruiting
First Posted : August 26, 2013
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Biotronik Canada Inc
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

August 21, 2013
August 26, 2013
April 27, 2018
October 2013
October 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01928498 on ClinicalTrials.gov Archive Site
  • 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.
  • 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)
  • 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
  • Drug eluting balloon safety [ Time Frame: 3 months ]
    Proportion of patients with side effects in the 2 groups.
Same as current
Not Provided
Not Provided
 
Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
  • Arteriovenous Fistulae
  • Arteriovenous Graft
  • Device: Paclitaxel Eluting Balloon Angioplasty
    Other Name: Passeo-18 Lux
  • Device: Percutaneous Transluminal Angioplasty (PTA)
    Other Name: Passeo-18
  • Experimental: Paclitaxel Eluting Balloon
    Paclitaxel Eluting Balloon Angioplasty
    Intervention: Device: Paclitaxel Eluting Balloon Angioplasty
  • Active Comparator: Conventional uncoated balloon
    Percutaneous Transluminal Angioplasty (PTA)
    Intervention: Device: Percutaneous Transluminal Angioplasty (PTA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
140
April 2019
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01928498
CE13.093 (2014-5032)
No
Not Provided
Not Provided
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Biotronik Canada Inc
Principal Investigator: Éric Therasse, MD Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP