MedTrace Logo

High Pressure Balloon vs Cutting Balloon

NCT03145662 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-06-06

No results posted yet for this study

Summary

Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.

Conditions

  • End Stage Renal Failure on Dialysis

Interventions

DEVICE

high pressure balloon

high pressure balloon will be used to treat stenosis

DEVICE

cutting balloon

cutting balloon will be used to treat stenosis

Sponsors & Collaborators

  • University of Toledo Health Science Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2019-03-23
Completion
2019-03-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03145662 on ClinicalTrials.gov