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Sponsors and Collaborators: |
Henry Ford Health System Boston Scientific Corporation |
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Information provided by: | Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT00543348 |
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:
Condition | Intervention |
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Stenosis |
Procedure: CUTTING BALLOON ANGIOPLASTY Procedure: HIGH PRESSURE BALLOON |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
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1: Active Comparator
CUTTING BALLOON
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Procedure: CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
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2: Placebo Comparator |
Procedure: CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
Procedure: HIGH PRESSURE BALLOON
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Henry Ford Hospital | Recruiting |
DETROIT, Michigan, United States, 48202 | |
Contact: GEORGES HADDAD, MD, FACS 313-916-7308 ghaddad1@hfhs.org | |
Principal Investigator: GEORGES HADDAD, MD, FACS | |
Sub-Investigator: STAVROS KAKKOS, MD, PhD |
Principal Investigator: | GEORGES HADDAD, MD, FACS | Henry Ford Health System |
Study ID Numbers: | HFHIRB4244 |
Study First Received: | October 11, 2007 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00543348 |
Health Authority: | United States: Institutional Review Board |
BALLOON ANGIOPLASTY AUTOGENOUS FISTULA |
Pathological Conditions, Anatomical Cardiovascular Abnormalities Arteriovenous Fistula Vascular Malformations Vascular Diseases |
Arteriovenous Malformations Constriction, Pathologic Congenital Abnormalities Fistula |
Vascular Fistula Cardiovascular Diseases |