Clinical trial NCT01928498: Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis
Official title: Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistulae
Arteriovenous Graft
Keywords: arteriovenous fistulae
arteriovenous graft
restenosis
angioplasty
drug eluting balloon
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Biotronik Canada Inc
First posted: 2013-08-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty)
timeFrame: 6 months
Secondary outcomes:
measure: The angiographic percentage of diameter stenosis and the incidence of angiographic binary restenosis rate (≥50% of the diameter of the reference-vessel segment)
timeFrame: 6 months
measure: Change of HA flow
timeFrame: Before angioplasty, week 1, month 1or month 3
measure: The rate of HA failure
timeFrame: 3 months
measure: Drug eluting balloon safety
timeFrame: 3 months
Other outcomes:
Locations:
city: Longueuil
country: Canada
facility: Hôpital Charles-Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'université de Montréal-CHUM
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Éric Therasse, MD
role: PRINCIPAL_INVESTIGATOR
References: