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

This study is currently recruiting participants.

Verified by Henry Ford Health System, October 2007

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:

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.

Condition	Intervention
Stenosis	Procedure: CUTTING BALLOON ANGIOPLASTY Procedure: HIGH PRESSURE BALLOON

MedlinePlus related topics: Angioplasty Fistulas

U.S. FDA Resources

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

Further study details as provided by Henry Ford Health System:

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Arteriovenous prosthetic grafts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543348

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

Sponsors and Collaborators

Henry Ford Health System

Boston Scientific Corporation

Investigators

Principal Investigator:

GEORGES HADDAD, MD, FACS

Henry Ford Health System

More Information

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

Keywords provided by Henry Ford Health System:

BALLOON ANGIOPLASTY
AUTOGENOUS FISTULA

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Cardiovascular Abnormalities
Arteriovenous Fistula
Vascular Malformations
Vascular Diseases

Arteriovenous Malformations
Constriction, Pathologic
Congenital Abnormalities
Fistula

Additional relevant MeSH terms:

Vascular Fistula
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009