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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Biotronik Canada Inc
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01928498
First received: August 21, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Arteriovenous Fistulae
Arteriovenous Graft
Device: Paclitaxel Eluting Balloon Angioplasty
Device: Percutaneous Transluminal Angioplasty (PTA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Difference between mean HA flow in the two groups (measured at the same times)

  • The rate of HA failure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Proportion of patients with side effects in the 2 groups.


Estimated Enrollment: 140
Study Start Date: October 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel Eluting Balloon
Paclitaxel Eluting Balloon Angioplasty
Device: Paclitaxel Eluting Balloon Angioplasty
Other Name: Passeo-18 Lux
Active Comparator: Conventional uncoated balloon
Percutaneous Transluminal Angioplasty (PTA)
Device: Percutaneous Transluminal Angioplasty (PTA)
Other Name: Passeo-18

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928498

Contacts
Contact: Jennifer Satterthwaite, M.Sc. 514-890-8000 ext 23483 jennifer.satterthwaite.chum@ssss.gouv.qc.ca
Contact: Andrée Cliche, RN, M.Sc. 514-890-8000 ext 28212 andree.cliche.chum@ssss.gouv.qc.ca

Locations
Canada, Ontario
University Health Network (UHN) Not yet recruiting
Toronto, Ontario, Canada, M5G 2N2
Sub-Investigator: Kongteng Tan, MD         
Canada, Quebec
Centre Hospitalier de l'université de Montréal-CHUM Not yet recruiting
Montreal, Quebec, Canada, H2L 4M1
Sub-Investigator: Gilles Soulez, MD.M.Sc.         
Sub-Investigator: Jean Éthier, MD         
Principal Investigator: Éric Therasse, MD         
Hôpital Maisonneuve-Rosemont Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Sub-Investigator: Georges Ouellet, MD         
Sub-Investigator: Véronique Caty, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Biotronik Canada Inc
Investigators
Principal Investigator: Éric Therasse, MD Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01928498     History of Changes
Other Study ID Numbers: CE13.093 (2014-5032)
Study First Received: August 21, 2013
Last Updated: August 21, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
arteriovenous fistulae
arteriovenous graft
restenosis
angioplasty
drug eluting balloon

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014