RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
March 7, 2022 updated by: loay kabbani, MD, Henry Ford Health System
A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters
Exclusion Criteria:
- Arteriovenous prosthetic grafts
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
CUTTING BALLOON ANGIOPLASTY
|
CUTTING BALLOON
|
|
Placebo Comparator: 2
Balloon angioplasty with a high pressure balloon
|
CUTTING BALLOON
HIGH PRESSURE BALLOON
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary and assisted patency
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: GEORGES HADDAD, MD, FACS, Henry Ford Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Anticipated)
March 1, 2008
Study Completion (Anticipated)
March 1, 2008
Study Registration Dates
First Submitted
October 11, 2007
First Submitted That Met QC Criteria
October 11, 2007
First Posted (Estimate)
October 12, 2007
Study Record Updates
Last Update Posted (Actual)
March 21, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFHIRB4244
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.