NCT03145662

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2019

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

March 24, 2017

Last Update Submit

June 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stenosis Rate

    days of stenosis free period

    2 years

Study Arms (2)

high pressure balloon

ACTIVE COMPARATOR

randomized to have dialysis fistula or AV graft treated with high pressure balloon

Device: high pressure balloon

cutting balloon

ACTIVE COMPARATOR

randomized to have dialysis fistula or AV graft treated with cutting balloon

Device: cutting balloon

Interventions

high pressure balloon will be used to treat stenosis

high pressure balloon

cutting balloon will be used to treat stenosis

cutting balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years of age
  • AV fistula or graft
  • Undergoing weekly hemodialysis
  • Patients must agree to the terms of the study and sign an informed Consent

You may not qualify if:

  • \. Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTMC

Toledo, Ohio, 43614, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomization to either high pressure balloon or cutting balloon
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 24, 2017

First Posted

May 9, 2017

Study Start

March 23, 2017

Primary Completion

March 23, 2019

Study Completion

March 23, 2019

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations