The Boston Scientific ACCESS Trial

Stopped early · Phase 2/Phase 3

Conditions studied: Renal Disease, Kidney Failure

In brief

The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis.

Key facts

Study ID

NCT00260728

Run by

Maquet Cardiovascular

People needed

149

Starts

2005-12-01

Expected to finish

2008-12-01

Last updated by the study team

2012-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Need for early dialysis access (≤72 hours after implantation):
• Initiation of maintenance dialysis is recommended per K/DOQI or institutional guidelines; or
• Patient is currently receiving dialysis via catheter
• No prior implantation of synthetic graft in the arm to be treated
• Life expectancy of at least 2 years, based on physician's assessment of medical condition

You may not qualify if…

• Patient younger than 18 years of age
• Any stenosis in the veins proximal to (downstream of) implant site, as determined previously or by current ultrasound
• Pregnancy
• Bleeding disorder, e.g., low platelet count (<50,000), hypercoagulable state, e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating Lupus anticoagulant; current, active heparin-induced thrombocytopenia; Protein C or S deficiency; or history of recurrent deep vein thrombosis not related to AV access.
• Active malignancy, e.g., condition either being treated or considered untreatable
• Active systemic infection, e.g., condition either being treated or considered untreatable
• Uncontrolled major symptomatic medical problem, e.g., undiagnosed severe pain, metabolic disturbance, fever, etc.
• Likelihood of poor compliance to required dialysis protocol, e.g., history of poor attendance to required clinic sessions or non-compliance to medication
• Mental incapacity; inability to understand treatment instructions
• Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study

Where it is running

• Long Beach VA Medical Center — Long Beach, California, United States
• Saint Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• VA New Jersey Healthcare System — East Orange, New Jersey, United States
• New York - Presbyterian, Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Texas Southwestern / VA Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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