Aortoiliac AneurysmsNCT02475798
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation
A study testing Zenith® Branch Endovascular Graft-Iliac Bifurcation, in people with Aortoiliac Aneurysms and Iliac Aneurysms, run by Cook Research Incorporated at 26 sites in United States.
Trial summary
The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortoiliac Aneurysms, Iliac Aneurysms
- What is being tested?
- Zenith® Branch Endovascular Graft-Iliac Bifurcation,
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 26 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
- An aortoiliac or iliac aneurysm of appropriate size
- Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery
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
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Emory University
Atlanta, Georgia, 30322
Christine E. Lynn Heart and Vascular Institute
Boca Raton, Florida, 33431
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
UT Southwestern
Dallas, Texas, 75235
South Florida Medical Imaging
Fort Lauderdale, Florida, 33308
University of Florida
Gainesville, Florida, 32610
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky Hospital
Lexington, Kentucky, 40536
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, 53215
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical Center
New York, New York, 10065
VA Palo Alto HCS
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Foundation for Medical Education and Research
Phoenix, Arizona, 85054
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
St. Anthony's Medical Center
Rockford, Illinois, 61108
William Beaumont Hospital
Royal Oak, Michigan, 48073
Washington University School of Medicine
St Louis, Missouri, 63110
Mercy Hospital East Communities
St Louis, Missouri, 63141
Stanford University Medical Center
Stanford, California, 94305
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Clinical Study to Collect Confirmatory Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.
- Conditions
- Aortoiliac Aneurysms, Iliac Aneurysms
- Being tested
- Zenith® Branch Endovascular Graft-Iliac Bifurcation,
- Keywords
- Zenith aortoiliac aneurysm, Iliac aneurysm, Branch, Connections, Endovascular graft, Graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases
- Medical subject headings
- Iliac Aneurysm, Aneurysm, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith® Branch Endovascular Graft-Iliac Bifurcation,Device
Also called Branch Graft
Implantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortoiliac 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 Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- W. Anthony Lee, MD, Principal investigator, Christine E. Lynn Heart and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475798
- Sponsor's protocol ID
- 05-625 CA-P2
- Status last verified
- Dec 2020
- First submitted
- 15 Jun 2015
- Last updated
- 16 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Collect Confirmatory Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
- ClinicalTrials.gov ID
- NCT02475798
- Acronym / sponsor ID
- 05-625 CA-P2
- Conditions
- Aortoiliac Aneurysms, Iliac Aneurysms
- Keywords
- Zenith aortoiliac aneurysm, Iliac aneurysm, Branch, Connections, Endovascular graft, Graft-iliac bifurcation, Aneurysm, Vascular Diseases
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 19 Jun 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 purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and 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 (2 listed)
- An aortoiliac or iliac aneurysm of appropriate size
- Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery
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® Branch Endovascular Graft-Iliac Bifurcation,Also: Branch GraftImplantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft. | 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 16 Dec 2020.
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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.
W. Anthony Lee, MD principal investigator
Christine E. Lynn Heart and Vascular Institute
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith® Branch Endovascular Graft-Iliac Bifurcation, in people with Aortoiliac Aneurysms and Iliac Aneurysms, run by Cook Research Incorporated at 26 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 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 16 Dec 2020.