Clinical trial NCT00260728: The Boston Scientific ACCESS Trial
Official title: ACCESS: Prospective, Multi-center Trial of the Fusion Vascular Access Graft for Patients Who Require Early Vascular Access for Hemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Renal Disease
Kidney Failure
Keywords: vascular access
hemodialysis
Lead sponsor: Maquet Cardiovascular
Sponsor class: INDUSTRY
First posted: 2005-12-02
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 primary objective is to demonstrate that secondary patency at 6 months for the Fusion™ Vascular Access Graft is not less than an objective performance criterion (OPC) minus a clinically relevant margin (δ). The OPC represents secondary patency at 6 months for the standard of care access grafts.

The secondary safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through 24 months post implant procedure, or through discharge for patients with unsuccessful device implantation. Secondary efficacy endpoints include:primary patency; primary assisted patency; ability to revise a failed graft; early access capability; time to hemostasis.

Subjects will undergo a thorough medical assessment and physical examination pre-procedure and will be assessed peri-procedure. Enrolled subjects with a device implanted will be evaluated at 1, 6, 12, 18 and 24 months post implant procedure.

Eligibility criteria: Inclusion Criteria:

1. 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
2. No prior implantation of synthetic graft in the arm to be treated
3. Life expectancy of at least 2 years, based on physician's assessment of medical condition

Exclusion Criteria:

1. Patient younger than 18 years of age
2. Any stenosis in the veins proximal to (downstream of) implant site, as determined previously or by current ultrasound
3. Pregnancy
4. 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.
5. Active malignancy, e.g., condition either being treated or considered untreatable
6. Active systemic infection, e.g., condition either being treated or considered untreatable
7. Uncontrolled major symptomatic medical problem, e.g., undiagnosed severe pain, metabolic disturbance, fever, etc.
8. Likelihood of poor compliance to required dialysis protocol, e.g., history of poor attendance to required clinic sessions or non-compliance to medication
9. Mental incapacity; inability to understand treatment instructions
10. Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study

Primary outcomes:
measure: Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Atlanta
country: United States
facility: Saint Joseph's Hospital of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: East Orange
country: United States
facility: VA New Jersey Healthcare System
state: New Jersey
city: New York
country: United States
facility: New York - Presbyterian, Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern / VA Medical Center
state: Texas
Study officials:
affiliation: Washington University School of Medicine, Barnes Jewish Hospital
name: Luis Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References: