Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT01928498
• Date of registration: 21/08/2013
• Prospective Registration: Yes
• Primary sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Public title: Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis DEB
• Scientific title: Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)
• Date of first enrolment: October 2013
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01928498
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Éric Therasse, MD
• Affiliation: Centre hospitalier de l'Université de Montréal (CHUM)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arteriovenous Fistulae

Arteriovenous Graft

Intervention(s)

Device: Paclitaxel Eluting Balloon Angioplasty

Device: Percutaneous Transluminal Angioplasty (PTA)

Primary Outcome(s)

Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty) [Time Frame: 6 months]

Secondary Outcome(s)

Change of HA flow [Time Frame: Before angioplasty, week 1, month 1or month 3]

Drug eluting balloon safety [Time Frame: 3 months]

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 rate of HA failure [Time Frame: 3 months]

Secondary ID(s)

CE13.093 (2014-5032)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biotronik Canada Inc