Renal DiseasePhase 2/3ACCESSNCT00260728
The Boston Scientific ACCESS Trial
A Phase 2/3 study testing vascular access graft implantation in people with Renal Disease and Kidney Failure, run by Maquet Cardiovascular at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease, Kidney Failure
- What is being tested?
- vascular access graft implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2005to Dec 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612-3824
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Texas Southwestern / VA Medical Center
Dallas, Texas, 75216
VA New Jersey Healthcare System
East Orange, New Jersey, 07018
Long Beach VA Medical Center
Long Beach, California, 90822
New York - Presbyterian, Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Disease, Kidney Failure
- Being tested
- vascular access graft implantation
- Keywords
- vascular access, hemodialysis
- Medical subject headings
- Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular access graft implantationDevice
vascular access graft implantation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Device: vascular access graft implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionMay 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maquet Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Sanchez, MD, Principal investigator, Washington University School of Medicine, Barnes Jewish Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260728
- Sponsor's protocol ID
- S2100
- Other IDs
- G050151
- Acronym
- ACCESS
- Status last verified
- Jun 2012
- First submitted
- 30 Nov 2005
- Last updated
- 27 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS: Prospective, Multi-center Trial of the Fusion Vascular Access Graft for Patients Who Require Early Vascular Access for Hemodialysis
- ClinicalTrials.gov ID
- NCT00260728
- Acronym / sponsor ID
- ACCESS / S2100
- Conditions
- Renal Disease, Kidney Failure
- Keywords
- vascular access, hemodialysis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Maquet CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: vascular access graft implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Need for early dialysis access (≤72 hours after implantation):
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vascular access graft implantationvascular access graft implantation | Device | Arm 1 |
Primary outcome
Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis
Time frame: 6 Months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Sanchez, MD principal investigator
Washington University School of Medicine, Barnes Jewish Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing vascular access graft implantation in people with Renal Disease and Kidney Failure, run by Maquet Cardiovascular at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012.