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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

November 30, 2005
June 26, 2012
December 2005
May 2007   (final data collection date for primary outcome measure)
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 ]
Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis
Complete list of historical versions of study NCT00260728 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Boston Scientific ACCESS Trial
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Disease
  • Kidney Failure
Device: vascular access graft implantation
vascular access graft implantation
Experimental: Arm 1
Intervention: Device: vascular access graft implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
149
December 2008
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00260728
S2100, G050151
Not Provided
Maquet Cardiovascular
Maquet Cardiovascular
Not Provided
Principal Investigator: Luis Sanchez, MD Washington University School of Medicine, Barnes Jewish Hospital
Maquet Cardiovascular
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP