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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00543348 |
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Date of registration:
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11/10/2007 |
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Primary sponsor: |
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Public title:
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RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
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Scientific title:
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A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00543348 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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GEORGES HADDAD, MD, FACS |
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Address:
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Telephone:
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313-916-7308 |
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Email:
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ghaddad1@hfhs.org |
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Affiliation:
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Name:
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GEORGES HADDAD, MD, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Henry Ford Health System |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Dysfunctional fistulas will be recruited based on the presence of clinical and
hemodialysis parameters
Exclusion Criteria:
- Arteriovenous prosthetic grafts
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stenosis
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Intervention(s)
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Procedure: CUTTING BALLOON ANGIOPLASTY
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Procedure: HIGH PRESSURE BALLOON
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Secondary ID(s)
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HFHIRB4244
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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