Randomized Fistula Study

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. Identifier: NCT00808561
Recruitment Status : Terminated (Slow enrollment due to multiple screen failures)
First Posted : December 16, 2008
Last Update Posted : March 11, 2016
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
The primary objective of this study is to compare two treatment strategies for establishing dialysis access in patients with unsuitable forearm veins for the standard forearm primary radio-cephalic arteriovenous fistula also known as the Brescia-Cimino fistula.

Condition or disease Intervention/treatment Phase
Renal Failure Other: Group 1: Alternative Fistula Other: Group 2: Forearm AV Graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Fistula vs. Forearm AV Graft in Patients With Poor Venous Access; Protocol #3, Version 1
Study Start Date : December 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Alternative Fistula Other: Group 1: Alternative Fistula
Performing other autogenous AV fistulas which include various options such as brachiocephalic AV fistula, basilic or brachial vein transpositions or a variety of other strategies to maintain a primary access. The advantage would be to maintain an autogenous all venous access with less risk of infection and thrombosis.
Active Comparator: 2 Forearm AV Graft Other: Group 2: Forearm AV Graft
a) ePTFE (polytetrafluoroethylene) bridge AV graft typically anastomosed in the proximal forearm to the radial or brachial artery and to an antecubital vein. The advantages include a quick maturation of 2-3 weeks, excellent flow rates and high technical success rates. Although secondary patency rates approach 80% at one year postoperatively, disadvantages include a more involved surgical procedure, a lower primary patency than a well functioning AV fistula, and higher revision and infection rates.4, 5

Primary Outcome Measures :
  1. The primary endpoint will be the rate of composite adverse events at one year with follow-up to 3 years. Data will be tabulated every 6 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Secondary endpoints: Primary, assisted primary, and secondary patency at 1 and 3 years [ Time Frame: 3 years ]
  2. Death due to access-related illness [ Time Frame: 3 years ]
  3. Death due to any cause [ Time Frame: 3 Years ]
  4. New central venous stenosis or occlusion [ Time Frame: 3 years ]
  5. Steal syndrome [ Time Frame: 3 years ]
  6. Neuropathy [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To participate in this study, the subject MUST have all of the following for inclusion in the study:

  • The subject must be > 18 years of age, male or female
  • Subject requires creation of dialysis access secondary to ESRD in the opinion of the referring nephrologist
  • Target arm may have a failed radiocephalic fistula
  • Contralateral failed or failing access may exist
  • The subject must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.

Exclusion Criteria:

To participate in this study, the subject may NOT HAVE any of the following at enrollment to the study:

  • Target arm has existing forearm AV graft, either functional or non-functional
  • Target arm has existing fistula, either functional or non-functional, other than a radio-cephalic at the wrist
  • Target arm has documented subclavian vein occlusion
  • Target arm has obviously suitable cephalic vein and radial artery for a primary radiocephalic fistula
  • Target arm has no superficial veins existing as options for primary access. If so, a second surgeon will review the ultrasound to confirm
  • Active local or systemic infection at the time of surgery
  • Known hypercoagulable state (e.g., antithrombin III deficiency, antiphospholipid or anticardiolipin antibodies, Factor IV Leiden, circulating lupus anticoagulant, history of heparin-induced thrombocytopenia, Protein C or S deficiency, prothrombin mutation or a history of recurrent deep venous thrombosis and/or pulmonary embolism)
  • Disseminated malignancy or other terminal condition where subject is expected to live less than 6 months.
  • Previous randomization in this trial

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 identifier (NCT number): NCT00808561

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Navyash Gupta, MD University of Pittsburgh Physicians

Responsible Party: University of Pittsburgh Identifier: NCT00808561     History of Changes
Other Study ID Numbers: Protocol #3, V1, Fistula
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical