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Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study

NCT05018962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-08-24

No results posted yet for this study

Summary

To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10).

We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.

Conditions

  • Dialysis Access Malfunction

Interventions

DEVICE

Cutting balloon followed by paclitaxel coated balloon

Cutting balloon followed by paclitaxel coated balloon

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Singapore General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-08
Primary Completion
2019-04-15
Completion
2020-03-18
FDA Device
Yes

Countries

  • Singapore

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 NCT05018962 on ClinicalTrials.gov