Aortic Aneurysm, AbdominalPhase 2NCT00615069
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
A Phase 2 study testing 31 mm GORE EXCLUDER® AAA Endoprosthesis in people with Aortic Aneurysm, Abdominal, run by W.L.Gore & Associates at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- 31 mm GORE EXCLUDER® AAA Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jun 2014
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infrarenal AAA > or equal to 4.5 cm in diameter
- Proximal infrarenal aortic neck length > or equal 15mm
- Anatomy meets 31mm EXCLUDER specification criteria
- Access vessel able to receive 20 Fr. introducer sheath
- Life expectancy >2 years
- Surgical candidate
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- ASA Class I, II, III, or IV
- NYHA Class I, II, III
- 21 years of age or older
- Male or infertile female
- Ability to comply with protocol requirements including follow-up
- Signed Informed Consent Form
Who cannot join
- Mycotic or ruptured aneurysm
- Participating in another investigational device or drug study within 1 year
- Documented history of drug abuse within 6 months
- Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
- Myocardial infarction or cerebral vascular accident within 6 weeks
- Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function
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- Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis
- Iliac anatomy that would require occlusion of both internal iliac arteries
- "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 same position of the aorta or iliac arteries
- Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome
- Proximal neck angulation > 60 degrees
- Presence of significant thrombus at arterial implantation sites
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms
Read the detailed description
The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- 31 mm GORE EXCLUDER® AAA Endoprosthesis
- 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.
31 mm GORE EXCLUDER® AAA EndoprosthesisDevice
Also called GORE EXCLUDER® Bifurcated Endoprosthesis
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
| Study group | Role | What they receive |
|---|---|---|
| 31 mm GORE EXCLUDER® Test Subjects | Experimental | GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA) Receives: Device: 31 mm GORE EXCLUDER® AAA Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year
Measured: Treatment through 1 year post-procedure (365 days)
Secondary outcomes (1)
Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications
Measured: Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startMay 2006
- Primary completionMar 2008
- Study completionJun 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon S Matsumura, M.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615069
- Sponsor's protocol ID
- AAA 03-02
- Status last verified
- Mar 2015
- First submitted
- 20 Dec 2007
- Last updated
- 14 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT00615069
- Acronym / sponsor ID
- AAA 03-02
- Conditions
- Aortic Aneurysm, Abdominal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Posted 9 Jul 2009
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 assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms
Detailed description
The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 31 mm GORE EXCLUDER® Test Subjects | Experimental | Device: 31 mm GORE EXCLUDER® AAA EndoprosthesisGORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Infrarenal AAA > or equal to 4.5 cm in diameter
- Proximal infrarenal aortic neck length > or equal 15mm
- Anatomy meets 31mm EXCLUDER specification criteria
- Access vessel able to receive 20 Fr. introducer sheath
- Life expectancy >2 years
Key exclusion criteria (14 listed)
- Mycotic or ruptured aneurysm
- Participating in another investigational device or drug study within 1 year
- Documented history of drug abuse within 6 months
- Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
- Myocardial infarction or cerebral vascular accident within 6 weeks
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 |
|---|---|---|
| 31 mm GORE EXCLUDER® AAA EndoprosthesisAlso: GORE EXCLUDER® Bifurcated EndoprosthesisGORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA) | Device | 31 mm GORE EXCLUDER® Test Subjects |
Primary outcome
Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year
Time frame: Treatment through 1 year post-procedure (365 days)
1 secondary outcome
Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications
Time frame: Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- 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.
Jon S Matsumura, M.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 31 mm GORE EXCLUDER® AAA Endoprosthesis in people with Aortic Aneurysm, Abdominal, run by W.L.Gore & Associates at 1 site 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 12 inclusion and 14 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 9 Jul 2009). 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?
Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year (time frame: Treatment through 1 year post-procedure (365 days)). 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 14 Apr 2015.