Abdominal Aortic AneurysmsNCT02557659
Zenith® Low Profile AAA Endovascular Graft
A study testing Zenith Low Profile AAA Endovascular Graft in people with Abdominal Aortic Aneurysms and Iliac Aneurysms, run by Cook Group Incorporated at 22 sites in United States.
Trial summary
This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data. 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 Low Profile AAA Endovascular Graft
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 22 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
- •Subject has at least one of the following
- Aortic or aortoiliac aneurysm
- Iliac aneurysm
- Aneurysm with a history of growth
Who cannot join
- Less than 18 years of age
- Inability or refusal to give informed consent
- Life expectancy less than 2 years
- Pregnant of breastfeeding or planning on becoming pregnant with 60 months
- Unwilling to comply with the follow-up schedule
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Massachusetss General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43214
University of Florida
Gainesville, Florida, 32610
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Morristown Memorial Hospital
Morristown, New Jersey, 07960-6095
Yale New Haven School of Medicine
New Haven, Connecticut, 06510
New York University - Langone Medical Center
New York, New York, 10016
New York Presbyterian Hospital - Cornell
New York, New York, 10032
New York Presbyterian - Columbia
New York, New York, 10065-4870
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California San Francisco-VA
San Francisco, California, 94143-001
University of California, San Francisco
San Francisco, California, 94143
University of Washington-Harborview Medical Center
Seattle, Washington, 98104
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Mercy Hospital
St Louis, Missouri, 63141
Stanford University Medical School
Stanford, California, 94305
About this study
Official title: Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft
This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.
- Being tested
- Zenith 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 Low Profile AAA Endovascular GraftDevice
Treatment of patients with abdominal aortic, aorto-iliac, or iliac 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 posted23 Sep 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
- Investigators
- Ronald Fairman, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557659
- Sponsor's protocol ID
- 08-013 CA
- Status last verified
- Mar 2018
- First submitted
- 22 Sep 2015
- Last updated
- 12 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft
- ClinicalTrials.gov ID
- NCT02557659
- Acronym / sponsor ID
- 08-013 CA
- Keywords
- Low Profile, Abdominal Aortic Aneurysms, Endovascular
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 23 Sep 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.
This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- •Subject has at least one of the following
- Aortic or aortoiliac aneurysm
- Iliac aneurysm
- Aneurysm with a history of growth
Key exclusion criteria (5 listed)
- Less than 18 years of age
- Inability or refusal to give informed consent
- Life expectancy less than 2 years
- Pregnant of breastfeeding or planning on becoming pregnant with 60 months
- Unwilling to comply with the follow-up schedule
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 Low Profile AAA Endovascular GraftTreatment of patients with abdominal aortic, aorto-iliac, or iliac 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 12 Mar 2018.
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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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith Low Profile AAA Endovascular Graft in people with Abdominal Aortic Aneurysms and Iliac Aneurysms, run by Cook Group Incorporated at 22 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 4 inclusion and 5 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 12 Mar 2018.