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NCT00543348 Clinical Trial

RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses

Stenosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00543348
Other study ID # HFHIRB4244
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2007
Est. completion date March 2008

Study information
Verified date March 2022
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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: 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters Exclusion Criteria: - Arteriovenous prosthetic grafts

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
• Balloon angioplasty
HIGH PRESSURE BALLOON

Locations
Country Name City State
United States Henry Ford Hospital Detroit Michigan

Sponsors (2)
Lead Sponsor Collaborator
Henry Ford Health System Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary and assisted patency 6 months
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