RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
Primary Purpose
Stenosis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CUTTING BALLOON ANGIOPLASTY
Balloon angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Stenosis focused on measuring BALLOON ANGIOPLASTY, AUTOGENOUS FISTULA
Eligibility Criteria
Inclusion Criteria:
- Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters
Exclusion Criteria:
- Arteriovenous prosthetic grafts
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
CUTTING BALLOON ANGIOPLASTY
Balloon angioplasty with a high pressure balloon
Outcomes
Primary Outcome Measures
Primary and assisted patency
Secondary Outcome Measures
Full Information
NCT ID
NCT00543348
First Posted
October 11, 2007
Last Updated
March 7, 2022
Sponsor
Henry Ford Health System
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00543348
Brief Title
RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
Official Title
A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas.
2. SPECIFIC AIMS
Study endpoints will be:
Primary Endpoint
1. Primary and assisted patency at 6 months
Secondary Endpoints:
Procedure effectiveness/residual stenosis
Procedure-related complications
Primary patency and primary assisted patency 12 months
Secondary patency at 6 and 12 months
Number/type of secondary interventions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis
Keywords
BALLOON ANGIOPLASTY, AUTOGENOUS FISTULA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
CUTTING BALLOON ANGIOPLASTY
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Balloon angioplasty with a high pressure balloon
Intervention Type
Procedure
Intervention Name(s)
CUTTING BALLOON ANGIOPLASTY
Intervention Description
CUTTING BALLOON
Intervention Type
Procedure
Intervention Name(s)
Balloon angioplasty
Intervention Description
HIGH PRESSURE BALLOON
Primary Outcome Measure Information:
Title
Primary and assisted patency
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters
Exclusion Criteria:
Arteriovenous prosthetic grafts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GEORGES HADDAD, MD, FACS
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
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