Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis (DEB)
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|ClinicalTrials.gov Identifier: NCT01928498|
Recruitment Status : Recruiting
First Posted : August 26, 2013
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment|
|Arteriovenous Fistulae Arteriovenous Graft||Device: Paclitaxel Eluting Balloon Angioplasty Device: Percutaneous Transluminal Angioplasty (PTA)|
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 (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928498
|Contact: Jennifer Satterthwaite, M.Sc.||514-890-8000 ext firstname.lastname@example.org|
|Contact: Dominique Aubin, M.Sc.||514-890-8000 ext email@example.com|
|Longueuil, Quebec, Canada|
|Contact: Michèle Roy, RN, BSc, BScN 450-466-5000 ext 2471|
|Principal Investigator: Serge Cournoyer, MD|
|Montreal, Quebec, Canada, H1T 2M4|
|Sub-Investigator: Georges Ouellet, MD|
|Sub-Investigator: Véronique Caty, MD|
|Centre Hospitalier de l'université de Montréal-CHUM||Recruiting|
|Montreal, Quebec, Canada, H2L 4M1|
|Sub-Investigator: Gilles Soulez, MD.M.Sc.|
|Sub-Investigator: Jean Éthier, MD|
|Principal Investigator: Éric Therasse, MD|
|Principal Investigator:||Éric Therasse, MD||Centre hospitalier de l'Université de Montréal (CHUM)|