High Pressure Balloon vs Cutting Balloon

• Sponsor: University of Toledo Health Science Campus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03145662
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Failure on Dialysis	Device: high pressure balloon; Device: cutting balloon	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomization to either high pressure balloon or cutting balloonrandomization to either high pressure balloon or cutting balloon
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis
• Actual Study Start Date: Mar 23, 2017
• Anticipated Primary Completion Date: Mar 23, 2019
• Anticipated Study Completion Date: Mar 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: high pressure balloon randomized to have dialysis fistula or AV graft treated with high pressure balloon	Device: high pressure balloon; high pressure balloon will be used to treat stenosis
Active Comparator: cutting balloon randomized to have dialysis fistula or AV graft treated with cutting balloon	Device: cutting balloon; cutting balloon will be used to treat stenosis

Outcome Measures

Primary Outcome Measures

1. Stenosis Rate [2 years]

   days of stenosis free period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UTMC	Toledo	Ohio	United States	43614

Sponsors and Collaborators

• University of Toledo Health Science Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Toledo Health Science Campus
• ClinicalTrials.gov Identifier: NCT03145662
• Other Study ID Numbers: HPB vs CB
• First Posted: May 9, 2017
• Last Update Posted: Mar 7, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Kidney Failure, Chronic

Study Results

No Results Posted as of Mar 7, 2019