Abdominal Aortic Aneurysm (AAA)NCT01990950
Fenestrated AAA Endovascular Graft Post-Approval Study
A study testing Zenith® Fenestrated AAA Endovascular Graft in people with Abdominal Aortic Aneurysm (AAA) and Aorto-iliac Aneurysm, run by Cook Research Incorporated at 6 sites in United States.
Trial summary
This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm, Juxtarenal Aneurysm
- What is being tested?
- Zenith® Fenestrated AAA Endovascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2014to 12 Oct 2020
- Phase
- Interventional
- 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
- abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
- aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair
Who cannot join
- proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
- renal artery stenosis greater than 50 percent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado
Aurora, Colorado, 80045
Borgess Research Institute
Kalamazoo, Michigan, 49048
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53711
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
University of California-Davis
Sacramento, California, 95817
Wake Forest University Health
Winston-Salem, North Carolina, 27102
About this study
Official title: Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study
This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.
- Being tested
- Zenith® Fenestrated AAA Endovascular Graft
- Keywords
- Aneurysm, Aortic Aneurysm, Iliac Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm, Aortic Aneurysm, Iliac Aneurysm, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith® Fenestrated AAA Endovascular GraftDevice
The Zenith® Fenestrated AAA Endovascular Graft with the H\&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair
| Study group | Role | What they receive |
|---|---|---|
| Zenith® Fenestrated AAA Endovascular Graft | Experimental | Not described Receives: Device: Zenith® Fenestrated AAA Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success : AAA Related Mortality
patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMar 2014
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
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 Abdominal Aortic Aneurysm (AAA)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990950
- Sponsor's protocol ID
- 11-005
- Status last verified
- Sep 2021
- First submitted
- 18 Nov 2013
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study
- ClinicalTrials.gov ID
- NCT01990950
- Acronym / sponsor ID
- 11-005
- Keywords
- Aneurysm, Aortic Aneurysm, Iliac Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 14 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zenith® Fenestrated AAA Endovascular Graft | Experimental | Device: Zenith® Fenestrated AAA Endovascular Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
- aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair
Key exclusion criteria (2 listed)
- proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
- renal artery stenosis greater than 50 percent
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 |
|---|---|---|
| Zenith® Fenestrated AAA Endovascular GraftThe Zenith® Fenestrated AAA Endovascular Graft with the H\&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair | Device | Zenith® Fenestrated AAA Endovascular Graft |
Primary outcome
Treatment Success : AAA Related Mortality
Time frame: 5 years
patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith® Fenestrated AAA Endovascular Graft in people with Abdominal Aortic Aneurysm (AAA) and Aorto-iliac Aneurysm, run by Cook Research Incorporated at 6 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 2 inclusion and 2 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2021). 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?
Treatment Success : AAA Related Mortality (time frame: 5 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 5 Oct 2021.