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AcoArt III / Arterio-venous Fistula in China

NCT03366727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2022-07-27

No results posted yet for this study

Summary

This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.

Conditions

  • Arteriovenous Fistula Stenosis

Interventions

DEVICE

drug-coated balloon catheter （Orchid, Acotec）

After predilation, using drug-coated balloon catheter to cover the whole treated segment

DEVICE

plain balloon catheter (Admiral, medtronic)

After predilation, using plain balloon catheter to cover the whole treated segment

Sponsors & Collaborators

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Wei Guo · Chinese PLA General Hospital

  • Lan Zhang · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-06-01
Completion
2022-07-07

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 NCT03366727 on ClinicalTrials.gov