NCT00260728

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2005

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 27, 2012

Status Verified

June 1, 2012

Enrollment Period

1.4 years

First QC Date

November 30, 2005

Last Update Submit

June 26, 2012

Conditions

Renal DiseaseKidney Failure

Keywords

vascular accesshemodialysis

Outcome Measures

Primary Outcomes (1)

  • Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis

    6 Months

Study Arms (1)

Arm 1

EXPERIMENTAL
Device: vascular access graft implantation

Interventions

vascular access graft implantationDEVICE

vascular access graft implantation

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Long Beach VA Medical Center

Long Beach, California, 90822, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612-3824, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

VA New Jersey Healthcare System

East Orange, New Jersey, 07018, United States

Location

New York - Presbyterian, Columbia University Medical Center

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern / VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Kidney DiseasesRenal Insufficiency

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Luis Sanchez, MD

    Washington University School of Medicine, Barnes Jewish Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

December 1, 2005

Primary Completion

May 1, 2007

Study Completion

December 1, 2008

Last Updated

June 27, 2012

Record last verified: 2012-06

Locations

US(8)