We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00543348
Recruitment Status : Unknown
Verified October 2007 by Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : October 12, 2007
Last Update Posted : October 12, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
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:

  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.

Condition or disease Intervention/treatment
Stenosis Procedure: CUTTING BALLOON ANGIOPLASTY Procedure: HIGH PRESSURE BALLOON

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
CUTTING BALLOON
Procedure: CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
Placebo Comparator: 2 Procedure: CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
Procedure: HIGH PRESSURE BALLOON


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00543348     History of Changes
Other Study ID Numbers: HFHIRB4244
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: October 12, 2007
Last Verified: October 2007

Keywords provided by Henry Ford Health System:
BALLOON ANGIOPLASTY
AUTOGENOUS FISTULA

Additional relevant MeSH terms:
Constriction, Pathologic
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities