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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Withdrawn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
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stenosis focused on measuring BALLOON ANGIOPLASTY, AUTOGENOUS FISTULA

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 11, 2007
Last Updated
March 7, 2022
Sponsor
Henry Ford Health System
Collaborators
Boston Scientific Corporation
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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Withdrawn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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