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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Arteriovenous Fistulae; Arteriovenous Graft

Treatments: Device: Paclitaxel Eluting Balloon Angioplasty; Device: Percutaneous Transluminal Angioplasty (PTA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01928498

CE13.093 (2014-5032)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Paclitaxel Eluting Balloon

Experimental group

Description:

Paclitaxel Eluting Balloon Angioplasty

Treatment:

Device: Paclitaxel Eluting Balloon Angioplasty

Conventional uncoated balloon

Active Comparator group

Description:

Percutaneous Transluminal Angioplasty (PTA)

Treatment:

Device: Percutaneous Transluminal Angioplasty (PTA)