Abdominal Aortic AneurysmsNCT00875563
Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study
A study testing Zenith(R) Fenestrated AAA Endovascular Graft in people with Abdominal Aortic Aneurysms and Aorto-iliac Aneurysms, run by Cook Group Incorporated at 14 sites in United States.
Trial summary
The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) 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(R) Fenestrated AAA Endovascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 14 sitesUnited States
- Study dates
- Jan 2005to Sep 2015
- 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 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
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
Cleveland Clinic
Cleveland, Ohio, 44195
Shands Hospital
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, 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
Worcester, Massachusetts, 01655
About this study
Official title: Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft
The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.
- Being tested
- Zenith(R) 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(R) Fenestrated AAA Endovascular GraftDevice
The Zenith(R) 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zenith(R) Fenestrated AAA Endovascular Graft Receives: Device: Zenith(R) Fenestrated AAA Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Success
Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm.
A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair.
A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis.
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 posted3 Apr 2009 (estimated)
- Study startJan 2005
- Primary completionFeb 2011
- Study completionSep 2015
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875563
- Sponsor's protocol ID
- 04-541
- Other IDs
- 370015, FNCT
- Status last verified
- Mar 2016
- First submitted
- 19 Feb 2009
- Last updated
- 11 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft
- ClinicalTrials.gov ID
- NCT00875563
- Acronym / sponsor ID
- 04-541
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 30 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Zenith(R) Fenestrated AAA Endovascular GraftZenith(R) 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 (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(R) Fenestrated AAA Endovascular GraftThe Zenith(R) 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 | 1 |
Primary outcome
Number of Participants With Treatment Success
Time frame: 6 months
Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm. A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair. A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Zenith abdominal aortic aneurysm endovascular graftLink provided by the sponsor.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith(R) Fenestrated AAA Endovascular Graft in people with Abdominal Aortic Aneurysms and Aorto-iliac Aneurysms, run by Cook Group Incorporated at 14 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: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 30 Sep 2015). 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 Participants With Treatment Success (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 11 Jan 2017.