The Boston Scientific ACCESS Trial (ACCESS)

ACCESS: Prospective, Multi-center Trial of the Fusion Vascular Access Graft for Patients Who Require Early Vascular Access for Hemodialysis

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.

Study Overview

• Status: Terminated
• Conditions: Kidney Failure; Renal Disease
• Intervention / Treatment: Device: vascular access graft implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Long Beach VA Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Saint Joseph's Hospital of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60612-3824
      • Rush University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New Jersey
    • East Orange, New Jersey, United States, 07018
      • VA New Jersey Healthcare System
  • New York
    • New York, New York, United States, 10032
      • New York - Presbyterian, Columbia University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Texas
    • Dallas, Texas, United States, 75216
      • University of Texas Southwestern / VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Device: vascular access graft implantation; vascular access graft implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis	6 Months

Collaborators and Investigators

• Sponsor: Maquet Cardiovascular
• Investigators: Principal Investigator: Luis Sanchez, MD, Washington University School of Medicine, Barnes Jewish Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (ACTUAL): May 1, 2007
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: November 30, 2005
• First Submitted That Met QC Criteria: November 30, 2005
• First Posted (ESTIMATE): December 2, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: hemodialysis; vascular access
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: S2100; G050151