Aortoiliac AneurysmsNCT02571907
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
A study testing Zenith® Branch Endovascular Graft-Iliac Bifurcation,, Atrium iCAST™ and Zenith® Flex AAA Endovascular Graft in people with Aortoiliac Aneurysms and Iliac Aneurysms, run by Cook Research Incorporated at 28 sites in United States.
Trial summary
The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a 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,, Atrium iCAST™ and Zenith® Flex AAA Endovascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 28 sitesUnited States
- Study dates
- 1 Apr 2014to 4 Nov 2020
- 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
- An aortioiliac or iliac aneurysm
- An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac 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
- Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
- Unwilling or unable to comply with the follow-up schedule
- Simultaneously participating in another investigative device or drug study
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Emory University Hospital
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
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
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
University of Nebraska
Omaha, Nebraska, 68105
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 School
Stanford, California, 94305
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.
- Conditions
- Aortoiliac Aneurysms, Iliac Aneurysms
- Being tested
- Zenith® Branch Endovascular Graft-Iliac Bifurcation,, Atrium iCAST™, Zenith® Flex AAA Endovascular Graft
- 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 Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™Device
Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular GraftDevice
Implantation of the Zenith Flex Endovascular Graft
| Study group | Role | What they receive |
|---|---|---|
| Zenith® Branch Endovascular Graft-Iliac Bifurcation | Experimental | Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft Receives: Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,; Device: Atrium iCAST™; Device: Zenith® Flex AAA Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms.
Measured: 6 months
Secondary outcomes (1)
Freedom From Morbidity (i.e., Morbidity Index)
Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start1 Apr 2014
- Primary completionNov 2015
- Study completion4 Nov 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- W. Anthony Lee, MD FACS, Principal investigator, Christine E. Lynn Heart and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571907
- Sponsor's protocol ID
- 05-625 P2
- Status last verified
- Jun 2025
- First submitted
- 28 Sep 2015
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
- Expanded access
- Available
Publications
Lee WA, Mantese V, Lee JT, Long G, Cable D, Hu M. Five-year outcomes of the PRESERVE II Zenith iliac branch pivotal clinical study. J Vasc Surg. 2026 Feb;83(2):413-421.e2. doi: 10.1016/j.jvs.2025.09.052. Epub 2025 Oct 9.
PubMed 41067585
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
- ClinicalTrials.gov ID
- NCT02571907
- Acronym / sponsor ID
- 05-625 P2
- Conditions
- Aortoiliac Aneurysms, Iliac Aneurysms
- Keywords
- Zenith aortoiliac aneurysm, Iliac aneurysm, Branch, Connections, Endovascular graft, Graft-iliac bifurcation, Aneurysm, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Posted 16 Jul 2025
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 evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac 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 |
|---|---|---|
| Zenith® Branch Endovascular Graft-Iliac Bifurcation | Experimental | Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,, Device: Atrium iCAST™, Device: Zenith® Flex AAA Endovascular GraftZenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex 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 (2 listed)
- An aortioiliac or iliac aneurysm
- An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
- Unwilling or unable 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® Branch Endovascular Graft-Iliac Bifurcation,Also: Branch GraftImplantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation. | Device | Zenith® Branch Endovascular Graft-Iliac Bifurcation |
| Atrium iCAST™Implantation of Atrium iCAST | Device | Zenith® Branch Endovascular Graft-Iliac Bifurcation |
| Zenith® Flex AAA Endovascular GraftImplantation of the Zenith Flex Endovascular Graft | Device | Zenith® Branch Endovascular Graft-Iliac Bifurcation |
Primary outcome
Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms.
Time frame: 6 months
1 secondary outcome
Freedom From Morbidity (i.e., Morbidity Index)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41067585Lee WA, Mantese V, Lee JT, Long G, Cable D, Hu M. Five-year outcomes of the PRESERVE II Zenith iliac branch pivotal clinical study. J Vasc Surg. 2026 Feb;83(2):413-421.e2. doi: 10.1016/j.jvs.2025.09.052. Epub 2025 Oct 9.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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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 FACS principal investigator
Christine E. Lynn Heart and Vascular Institute
28 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,, Atrium iCAST™ and Zenith® Flex AAA Endovascular Graft in people with Aortoiliac Aneurysms and Iliac Aneurysms, run by Cook Research Incorporated at 28 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 6 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 16 Jul 2025). 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 Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02571907, which also lists 1 linked publication.
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 Jul 2025.