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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Henry Ford Health System.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543348
First Posted: October 12, 2007
Last Update Posted: October 12, 2007
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.
Collaborator:
Boston Scientific Corporation
Information provided by:
Henry Ford Health System
  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:

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Estimated Enrollment: 100
Study Start Date: September 2007
Arms Assigned Interventions
Active Comparator: 1
CUTTING BALLOON
Procedure: CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
Placebo Comparator: 2 Procedure: CUTTING BALLOON ANGIOPLASTY
CUTTING BALLOON
Procedure: HIGH PRESSURE BALLOON

  Eligibility

Information from the National Library of Medicine

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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 Submitted: October 11, 2007
First Posted: October 12, 2007
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