Aortic Aneurysm, AbdominalPhase 4NCT00593814
GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
A Phase 4 study testing GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in people with Aortic Aneurysm, Abdominal, run by W.L.Gore & Associates.
Trial summary
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
- Type of treatment
- Medical device
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Feb 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
- Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
- Access vessel able to receive 18 French introducer sheath
- Life expectancy > 2 years
- Appropriate candidate for endovascular repair
- Ability to comply with protocol requirements including follow-up
- 21 years of age or older, male or infertile female**
Who cannot join
- Mycotic or ruptured aneurysm
- Participating in another investigational device or drug study within one year
- Documented history of drug abuse within six months
- Myocardial infarction or cerebral vascular accident within six weeks
- Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
- Iliac anatomy that would require occlusion of both internal iliac arteries
Show all 10Show fewer
- Planned occlusion or reimplantation of significant mesenteric or renal arteries
- Planned concomitant surgical procedure or previous major surgery within 30 days
- Previous prosthesis placement in the aorta or iliac arteries
- Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)
About this study
Official title: A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE EXCLUDER® Bifurcated Endoprosthesis-Low PermeabilityDevice
Implant
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
Measured: 2 years
Secondary outcomes (1)
Number of Subjects With Device Efficacy Events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJun 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark F Fillinger, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593814
- Sponsor's protocol ID
- AAA 04-04
- Status last verified
- Dec 2017
- First submitted
- 20 Dec 2007
- Last updated
- 8 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT00593814
- Acronym / sponsor ID
- AAA 04-04
- Conditions
- Aortic Aneurysm, Abdominal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 23 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
- Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
- Access vessel able to receive 18 French introducer sheath
- Life expectancy > 2 years
- Appropriate candidate for endovascular repair
Key exclusion criteria (10 listed)
- Mycotic or ruptured aneurysm
- Participating in another investigational device or drug study within one year
- Documented history of drug abuse within six months
- Myocardial infarction or cerebral vascular accident within six weeks
- Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
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 |
|---|---|---|
| GORE EXCLUDER® Bifurcated Endoprosthesis-Low PermeabilityImplant | Device | – |
Primary outcome
Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
Time frame: 2 years
1 secondary outcome
Number of Subjects With Device Efficacy Events
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark F Fillinger, MD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in people with Aortic Aneurysm, Abdominal, run by W.L.Gore & Associates.
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 7 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: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure (time frame: 2 years). 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 8 Jan 2018.