High Pressure Balloon vs Cutting Balloon

End Stage Renal Failure on Dialysis Clinical Trial

Official title:

Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03145662
• Other study ID #: HPB vs CB
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2017
• Est. completion date: March 23, 2019

Study information

• Verified date: March 2019
• Source: University of Toledo Health Science Campus
• Contact: Munier Nazzal, MD
• Phone: 419-383-6810
• Email: munier.nazzal[@]utoledo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Data will be collected from standard of care visit, including physician visits and ultrasounds. Follow up will be based on the function of the AV access, dialysis center criteria and/or standard of care ultrasound results: including venous pressure of the AV access, difficult cannulation, urea recirculation, and change in character and sound of the AV access (thrill/bruit), which are standard of care assessment at a dialysis center. All patient data sheets will be kept in a study binder and locked in the research room. Randomization will be performed with a computer program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: March 23, 2019
• Est. primary completion date: March 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years of age

2. AV fistula or graft

3. Undergoing weekly hemodialysis

4. Patients must agree to the terms of the study and sign an informed Consent

Exclusion Criteria:

1. Pregnant women

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Device:
• high pressure balloon
high pressure balloon will be used to treat stenosis
• cutting balloon
cutting balloon will be used to treat stenosis

Locations

Country	Name	City	State
United States	UTMC	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stenosis Rate	days of stenosis free period	2 years