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Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

NCT06553443 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-08-14

No results posted yet for this study

Summary

To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty

Conditions

  • Arteriovenous Fistula
  • Arteriovenous Fistula Stenosis
  • Dialysis Access Malfunction

Interventions

DEVICE

Angioplasty of all peripheral AVF stenosis

All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

Sponsors & Collaborators

  • Singapore Clinical Research Institute

    collaborator OTHER

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Singapore General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-04
Primary Completion
2025-12-31
Completion
2029-12-31
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 NCT06553443 on ClinicalTrials.gov