Abdominal Aortic AneurysmsNCT00833924
Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
A study testing Zenith(R) Low Profile AAA Endovascular Graft in people with Abdominal Aortic Aneurysms and Iliac Aneurysms, run by Cook Group Incorporated at 27 sites in 5 countries.
Trial summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms, Iliac Aneurysms, Aorto-iliac Aneurysms
- What is being tested?
- Zenith(R) Low Profile AAA Endovascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 27 sitesin 5 countries
- Study dates
- May 2008to Jun 2016
- 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, aortoiliac, and iliac aneurysms of appropriate size
- Vessels suitable for endovascular access and aneurysm repair
Who cannot join
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Unsuitable arterial anatomy
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
United States23 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27955
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43214
Fairfax Inova Hospital
Falls Church, Virginia, 22042
University of Florida, Vascular Surgery
Gainesville, Florida, 32610
Spectrum Health Butterworth
Grand Rapids, Michigan, 49546
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Yale New Haven School of Med., Dept. of Vascular Surgery
New Haven, Connecticut, 06510
New York University Hospital
New York, New York, 10016
New York Presbyterian Hospital - Cornell
New York, New York, 10032
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester, Strong Memorial Hospital
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC
San Francisco, California, 94143
Harborview Medical Center
Seattle, Washington, 98104
Barnes-Jewish Hospital
St Louis, Missouri, 63141
Mercy Hospital
St Louis, Missouri, 63141
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.
- Being tested
- Zenith(R) Low Profile AAA Endovascular Graft
- Keywords
- Low Profile, Abdominal Aortic Aneurysms, Endovascular
- Medical subject headings
- Aortic Aneurysm, Abdominal, Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith(R) Low Profile AAA Endovascular GraftDevice
The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Treatment with Endovascular Graft Receives: Device: Zenith(R) Low Profile AAA Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Major Adverse Events (MAE)
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
Measured: 30-day
Patients With Device Failures
Device success at 12-month is defined as:
Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startMay 2008
- Primary completionOct 2011
- Study completionJun 2016
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Fairman, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833924
- Sponsor's protocol ID
- 08-013
- Other IDs
- 370016
- Status last verified
- Mar 2018
- First submitted
- 30 Jan 2009
- Last updated
- 4 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. 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) Low Profile AAA Endovascular Graft
- ClinicalTrials.gov ID
- NCT00833924
- Acronym / sponsor ID
- 08-013
- Keywords
- Low Profile, Abdominal Aortic Aneurysms, Endovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 29 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and 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 | Other | Device: Zenith(R) Low Profile AAA Endovascular GraftTreatment with 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, aortoiliac, and iliac aneurysms of appropriate size
- Vessels suitable for endovascular access and aneurysm repair
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Unsuitable arterial anatomy
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) Low Profile AAA Endovascular GraftThe Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair. | Device | 1 |
Primary outcome
Patients With Major Adverse Events (MAE)
Time frame: 30-day
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
Patients With Device Failures
Time frame: 12-month
Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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.
Ronald Fairman, MD principal investigator
University of Pennsylvania
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith(R) Low Profile AAA Endovascular Graft in people with Abdominal Aortic Aneurysms and Iliac Aneurysms, run by Cook Group Incorporated at 27 sites in 5 countries.
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 4 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 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, China, Germany, Russia, Sweden. 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 29 Jan 2016). 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?
Patients With Major Adverse Events (MAE) (time frame: 30-day). The study lists 2 primary outcomes in all. 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 4 Apr 2018.