Status:
TERMINATED
The Boston Scientific ACCESS Trial
Lead Sponsor:
Maquet Cardiovascular
Conditions:
Renal Disease
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
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. The primar...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00260728
Start Date
December 1 2005
End Date
December 1 2008
Last Update
June 27 2012
Active Locations (8)
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1
Long Beach VA Medical Center
Long Beach, California, United States, 90822
2
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
3
Rush University Medical Center
Chicago, Illinois, United States, 60612-3824
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215