The Boston Scientific ACCESS Trial

Kidney Failure Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00260728
• Other study ID #: S2100
• Secondary ID: G050151
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 30, 2005
• Last updated: June 26, 2012
• Start date: December 2005
• Est. completion date: December 2008

Study information

• Verified date: June 2012
• Source: Maquet Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 149
• Est. completion date: December 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Disease
• Renal Insufficiency

Intervention

Device:
• vascular access graft implantation
vascular access graft implantation

Locations

Country	Name	City	State
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas Southwestern / VA Medical Center	Dallas	Texas
United States	VA New Jersey Healthcare System	East Orange	New Jersey
United States	Long Beach VA Medical Center	Long Beach	California
United States	New York - Presbyterian, Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maquet Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis		6 Months	Yes