The Boston Scientific ACCESS Trial

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular
ClinicalTrials.gov Identifier:
NCT00260728
First received: November 30, 2005
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Renal Disease
Kidney Failure
Device: vascular access graft implantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ACCESS: Prospective, Multi-center Trial of the Fusion Vascular Access Graft for Patients Who Require Early Vascular Access for Hemodialysis

Resource links provided by NLM:


Further study details as provided by Maquet Cardiovascular:

Primary Outcome Measures:
  • Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment: 149
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Device: vascular access graft implantation
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260728

Locations
United States, California
Long Beach VA Medical Center
Long Beach, California, United States, 90822
United States, Georgia
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612-3824
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New Jersey
VA New Jersey Healthcare System
East Orange, New Jersey, United States, 07018
United States, New York
New York - Presbyterian, Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Texas
University of Texas Southwestern / VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Maquet Cardiovascular
Investigators
Principal Investigator: Luis Sanchez, MD Washington University School of Medicine, Barnes Jewish Hospital
  More Information

No publications provided

Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT00260728     History of Changes
Other Study ID Numbers: S2100, G050151
Study First Received: November 30, 2005
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Maquet Cardiovascular:
vascular access
hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on September 29, 2014