RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
NCT ID: NCT00543348
Last Updated: 2022-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2007-09-30
2008-03-31
Brief Summary
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2\. SPECIFIC AIMS
Study endpoints will be:
Primary Endpoint
1\. Primary and assisted patency at 6 months
Secondary Endpoints:
1. Procedure effectiveness/residual stenosis
2. Procedure-related complications
3. Primary patency and primary assisted patency 12 months
4. Secondary patency at 6 and 12 months
5. Number/type of secondary interventions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
2
Balloon angioplasty with a high pressure balloon
CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
Balloon angioplasty
HIGH PRESSURE BALLOON
Interventions
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CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
Balloon angioplasty
HIGH PRESSURE BALLOON
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Henry Ford Health System
OTHER
Responsible Party
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loay kabbani, MD
Vascular Surgeon
Principal Investigators
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GEORGES HADDAD, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Henry Ford Hospital
Detroit, Michigan, United States
Countries
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Other Identifiers
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HFHIRB4244
Identifier Type: -
Identifier Source: org_study_id
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