Abdominal Aortic AneurysmsNCT02577562
Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study
A study testing Zenith® Fenestrated AAA Endovascular Graft in people with Abdominal Aortic Aneurysms and Aorto-iliac Aneurysms, run by Cook Group Incorporated at 15 sites in United States.
Trial summary
The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms, Juxtarenal Aneurysms
- What is being tested?
- Zenith® Fenestrated AAA Endovascular Graft
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm
Who cannot join
- Proximal neck less than 4 mm 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
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Cleveland Clinic
Cleveland, Ohio, 44195
Shands Hospital
Gainesville, Florida, 32610
University of Florida
Gainesville, Florida, 32610
The Indiana Heart Hospital
Indianapolis, Indiana, 46250
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
NYU Medical Center
New York, New York, 10016
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94143
Harborview Medical Center
Seattle, Washington, 98104
Barnes-Jewish Hospital
St Louis, Missouri, 63110
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Zenith® Fenestrated AAA Endovascular Graft Clinical Study
The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.
- Being tested
- Zenith® Fenestrated AAA Endovascular Graft
- 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.
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 aneurysms having morphology suitable for endovascular repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577562
- Sponsor's protocol ID
- 04-541 CA
- Status last verified
- Nov 2017
- First submitted
- 14 Oct 2015
- Last updated
- 24 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® Fenestrated AAA Endovascular Graft Clinical Study
- ClinicalTrials.gov ID
- NCT02577562
- Acronym / sponsor ID
- 04-541 CA
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 16 Oct 2015 (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 Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm
Key exclusion criteria (2 listed)
- Proximal neck less than 4 mm 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 aneurysms having morphology suitable for endovascular repair | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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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.
15 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 Aneurysms and Aorto-iliac Aneurysms, run by Cook Group Incorporated at 15 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 1 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
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.
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 24 Nov 2017.