Aortic Aneurysm, AbdominalNCT04875429
Zenith® Fenestrated+ Clinical Study
A study testing Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 in people with Aortic Aneurysm, Abdominal and Juxtarenal Aortic Aneurysm, run by Cook Research Incorporated at 33 sites in 2 countries.
Trial summary
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal
- What is being tested?
- Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 8 Dec 2023to Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Age < 18 years
- Life expectancy < 2 years
- Pregnant, breast-feeding, or planning to become pregnant within 60 months
- Inability or refusal to give informed consent by the patient or legally authorized representative
- Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
- Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
Trial locations and contacts
33 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 2 countries
United States32 sites, 30 recruiting
- Recruiting
University of Michigan Health System
Ann Arbor, Michigan, 48109
Jonathan Eliason, MD
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Yazan Duwayri, MD
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Shahab Toursavadkohi, MD
- Recruiting
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35294
Adam Beck, MD
- Completed
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Marc Schermerhorn, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Federico Parodi, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Ravi Veeraswamy, MD
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Neel Mansukhani, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Francis Caputo, MD
- Recruiting
Ut Southwestern
Dallas, Texas, 75235
Mirza Baig, MD
- Recruiting
University of Florida Shands Hospital
Gainesville, Florida, 32610
Zain Shahid, MD
- Recruiting
Endeavor Health Cardiovascular Institute at Glenbrook Hospital
Glenview, Illinois, 60026
George Pontikis
- Recruiting
Memorial Hermann Texas Medical Center/UT Health
Houston, Texas, 77030
Naveed Saqib, MD
- Recruiting
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202
Andres Fajardo, MD
- Recruiting
Holston Valley Hospital
Kingsport, Tennessee, 37660
Robert "Bo" Allen, MD
- Recruiting
UC San Diego
La Jolla, California, 92037
Mahmoud Malas, MD
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Bjoern Suckow, MD
- Recruiting
University of Southern California
Los Angeles, California, 90031
Sukgu Han, MD
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Michael Soult, MD
- Recruiting
Edward Hospital
Naperville, Illinois, 60540
George Pontikis, MD
George Pontikis, MD
- Recruiting
New York University Langone Medical Center
New York, New York, 10016
Thomas Maldonado, MD
- Recruiting
Columbia University Irving Medical Center/NY Presbyterian Hospital
New York, New York, 10032
Virenda Patel
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Grace Wang, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Nathan Liang
- Active, not recruiting
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Randall DeMartino, MD
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
John Ohman, MD
- Recruiting
Stanford Hospitals and Clinics
Stanford, California, 94305
Jason Lee, MD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Dean Arnaoutakis, MD
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Steven Abramowitz, MD
- Recruiting
University of Massachusetts
Worcester, Massachusetts, 01655
Andres Schanzer, MD
United Kingdom1 site
- Active, not recruiting
St Thomas' Hospital
London, SE1 7EH
About this study
Official title: Zenith® Fenestrated+ Endovascular Graft Clinical Study
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
Up to 130 additional subjects may be enrolled in Continued Access phase of the study
- Conditions
- Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm
- Being tested
- Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
- Keywords
- endovascular, Vascular Diseases, Cardiovascular Diseases, Fenestration
- Medical subject headings
- Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2Device
Endovascular aneurysm repair
| Study group | Role | What they receive |
|---|---|---|
| Aortic abdominal aneurysm | Experimental | Not described Receives: Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of device technical success and procedural safety
Percent of patients with device technical success and freedom from procedural safety events in the following criteria:
- Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and
- Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
Measured: 30 days post procedure
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention
Percent of patients meeting the following criteria:
- Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and
- Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start8 Dec 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gustavo Oderich, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875429
- Sponsor's protocol ID
- 17-07
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 after publication of the results from this study and ending 5 years after initial publication. 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® Fenestrated+ Endovascular Graft Clinical Study
- ClinicalTrials.gov ID
- NCT04875429
- Acronym / sponsor ID
- 17-07
- Conditions
- Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm
- Keywords
- endovascular, Vascular Diseases, Cardiovascular Diseases, Fenestration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 6 May 2021 (actual)
- 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 Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
Up to 130 additional subjects may be enrolled in Continued Access phase of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic abdominal aneurysm | Experimental | Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Age < 18 years
- Life expectancy < 2 years
- Pregnant, breast-feeding, or planning to become pregnant within 60 months
- Inability or refusal to give informed consent by the patient or legally authorized representative
- Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
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 Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2Endovascular aneurysm repair | Device | Aortic abdominal aneurysm |
Primary outcome
Composite measure of device technical success and procedural safety
Time frame: 30 days post procedure
Percent of patients with device technical success and freedom from procedural safety events in the following criteria: 1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and 2. Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention
Time frame: 12 months post procedure
Percent of patients meeting the following criteria: 1. Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and 2. Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- 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 after publication of the results from this study and ending 5 years after initial publication. 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.
Gustavo Oderich, MD principal investigator
Baylor College of Medicine
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 in people with Aortic Aneurysm, Abdominal and Juxtarenal Aortic Aneurysm, run by Cook Research Incorporated at 33 sites in 2 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 0 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chanda Bell, RN, BSN (765-463-7537 ext. 321506, chanda.bell@cookmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure of device technical success and procedural safety (time frame: 30 days post procedure). 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 6 Oct 2026.