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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 because the information has not been verified recently.
Verified October 2007 by Henry Ford Health System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00543348
First received: October 11, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Angioplasty Fistulas
U.S. FDA Resources

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00543348     History of Changes
Other Study ID Numbers: HFHIRB4244
Study First Received: October 11, 2007
Last Updated: October 11, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013