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A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

NCT02962141 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2019-08-07

No results posted yet for this study

Summary

To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.

Conditions

  • Peripheral Arterial Disease
  • Fistula

Interventions

DEVICE

Paclitaxel Releasing Peripheral Balloon Dilatation Catheter

Treatment group

DEVICE

Balloon Dilatation Catheter

Control group

Sponsors & Collaborators

  • ZhuHai Cardionovum Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qizhuang Jin, professor · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-01-31
Completion
2019-06-30

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 NCT02962141 on ClinicalTrials.gov