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A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV

NCT04226599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-02-11

No results posted yet for this study

Summary

Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.

Conditions

  • Fistulas Arteriovenous

Interventions

DEVICE

Dissolve AVF

Subjects in the test group will be treated with peripheral scoring drug balloon.

DEVICE

Armada 35

Subjects in the test group will be treated with plain balloon catheter.

Sponsors & Collaborators

  • DK Medical Technology (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • YE CHAOYANG · ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2021-10-02
Completion
2022-01-04

Countries

  • China

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 NCT04226599 on ClinicalTrials.gov