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| Sponsors and Collaborators: |
Henry Ford Health System Boston Scientific Corporation |
| Information provided by: | Henry Ford Health System |
| ClinicalTrials.gov Identifier: | NCT00543348 |
Purpose
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 |
|
Stenosis |
Procedure: CUTTING BALLOON ANGIOPLASTY Procedure: HIGH PRESSURE BALLOON |
| MedlinePlus related topics: | Angioplasty Fistulas |
| 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 |
|
1: Active Comparator
CUTTING BALLOON
|
Procedure: CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
|
| 2: Placebo Comparator |
Procedure: CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
Procedure: HIGH PRESSURE BALLOON
|
Eligibility
| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |||||
| Henry Ford Health System |
| Boston Scientific Corporation |
| Principal Investigator: | GEORGES HADDAD, MD, FACS | Henry Ford Health System |
More Information
| Study ID Numbers: | HFHIRB4244 |
| First Received: | October 11, 2007 |
| Last Updated: | October 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00543348 |
| Health Authority: | United States: Institutional Review Board |
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