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

Tracking Information

First Received Date ^ICMJE

October 11, 2007

Last Updated Date

October 11, 2007

Start Date ^ICMJE

September 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses

Brief 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:

Procedure effectiveness/residual stenosis
Procedure-related complications
Primary patency and primary assisted patency 12 months
Secondary patency at 6 and 12 months
Number/type of secondary interventions.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Stenosis

Intervention ^ICMJE

Procedure: CUTTING BALLOON ANGIOPLASTY
Procedure: HIGH PRESSURE BALLOON

Study Arms / Comparison Groups

Active Comparator: CUTTING BALLOON

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters

Exclusion Criteria:

Arteriovenous prosthetic grafts

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00543348

Responsible Party

Study ID Numbers ^ICMJE

HFHIRB4244

Study Sponsor ^ICMJE

Henry Ford Health System

Collaborators ^ICMJE

Boston Scientific Corporation

Investigators ^ICMJE

Principal Investigator:

GEORGES HADDAD, MD, FACS

Henry Ford Health System

Information Provided By

Henry Ford Health System

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP