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Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)

NCT02408822 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-12-02

No results posted yet for this study

Summary

Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.

This randomized controlled trial is designed to prove the superiority of a drug-eluting balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients.

The hypothesis is that use of drug-eluting balloon will improve post-interventional patency of the access, and therefore, limit numbers and days of hospitalization for maintenance of hemodialysis vascular accesses.

Conditions

  • Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)

Interventions

DEVICE

PTA Balloon dilatation catheter Advance® (Cook® Medical)

2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure

DEVICE

Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®

2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • REDA HASSEN-KHODJA · Centre Hospitalier Universitaire de Nice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-29
Primary Completion
2020-06-15
Completion
2026-06-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408822 on ClinicalTrials.gov