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The SIR-POBA Shunt Trial

NCT06056206 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-29

No results posted yet for this study

Summary

The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an arteriovenous shunt stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment modality.

Conditions

  • Arteriovenous Fistula Stenosis

Interventions

RADIATION

Balloon Angioplasty

Revascularisation procedures will be performed according to randomised list.

Sponsors & Collaborators

  • MedAlliance Swiss Medical Technology

    collaborator UNKNOWN

  • Paracelsus Medical University

    lead OTHER

Principal Investigators

  • Stephanie Rassam, MD · Resident Physician

  • Manuela Pilz, MD PD FEBVS · Senior Physician

  • Klaus Linni, MD PD FEBVS · Head of Division of Vascular and Endovascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2025-10-01
Completion
2027-10-01

Countries

  • Austria

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 NCT06056206 on ClinicalTrials.gov