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Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula

NCT04393688 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2020-05-20

No results posted yet for this study

Summary

This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Conditions

  • Arteriovenous Fistula

Interventions

COMBINATION_PRODUCT

Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter

Procedure: Percutaneous Transluminal Angiography, Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Sponsors & Collaborators

  • CCRF Inc., Beijing, China

    collaborator INDUSTRY

  • BrosMed Medical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Qizhuang Jin · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2020-07-01
Completion
2021-05-01

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 NCT04393688 on ClinicalTrials.gov