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Paclitaxel-Coated Balloon for the Treatment of AVF

NCT05088083 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2021-10-21

No results posted yet for this study

Summary

To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.

Conditions

  • Arteriovenous Fistula

Interventions

DEVICE

Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

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

Sponsors & Collaborators

  • Zhejiang Zylox Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lan Zhang · RenJi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2023-03-31
Completion
2023-09-30

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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 NCT05088083 on ClinicalTrials.gov