Frontlight ResearchEarly access
Taking people in United StatesNo phase
Stent graft device for aortic aneurysms near the kidney arteries
Tests a stent graft system in adults with aortic aneurysms involving major abdominal arteries.
Key facts
- Who runs it
- Cook Research Incorporated
- Where
- Ann Arbor, Atlanta, Baltimore, Birmingham, Boston, Chapel Hill, Charleston, Chicago, Cleveland, Dallas, Gainesville, Glenview, Houston, Indianapolis, Kingsport, La Jolla, Lebanon, Los Angeles, Maywood, Naperville, New York, Philadelphia, Pittsburgh, Roanoke, Rochester, St Louis, Stanford, Tampa, Washington D.C., and Worcester, United StatesSee the 32 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- Zenith® Fenestrated+ Clinical Study
- Status
- Recruiting
- People taking part
- 105 people, planned
- Started
- 8 Dec 2023
- Expected to end
- Nov 2031
- Type of study
- Interventional
- Treatments tested
- Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
- Record updated
- 6 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an aortic aneurysm near or involving the arteries to the kidneys or gut. It tests the Zenith Fenestrated+ graft with BeGraft and Unibody2.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm. It must have a diameter ≥ 55 mm in males or ≥ 50 mm in females. Or it grew ≥ 5 mm in 6 months. Or the aorta is > 2x its normal diameter, or the aneurysm is saccular (pouch-shaped) and the investigator thinks it needs treatment.
Main reasons for not taking part
- Life expectancy under 2 years
- Pregnant, breast-feeding, or planning pregnancy within 60 months
- Unable or unwilling to give informed consent
- Unable or unwilling to follow the visits, tests and imaging
- In another study, unless at least 30 days past its main endpoint
The registry criteria, word for word
Show all 10 criteriaShow less
Who cannot take part
- Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
- 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
Other criteria
- Include Criteria:
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter > 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator
Where in United States
Also in 1 other country, 1 site
- University of Michigan Health SystemAnn Arbor, United StatesContact: Jonathan Eliason, MDTaking people
- Emory University HospitalAtlanta, United StatesContact: Yazan Duwayri, MDTaking people
- University of MarylandBaltimore, United StatesContact: Shahab Toursavadkohi, MDTaking people
- University of Alabama Birmingham HospitalBirmingham, United StatesContact: Adam Beck, MDTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesContact: Marc Schermerhorn, MDTaking people
- Massachusetts General HospitalBoston, United StatesContact: Chanda Bell, RN, BSNNo longer taking part
- University of North Carolina at Chapel HillChapel Hill, United StatesContact: Federico Parodi, MDTaking people
- Medical University of South CarolinaCharleston, United StatesContact: Ravi Veeraswamy, MDTaking people
- Northwestern Memorial HospitalChicago, United StatesContact: Neel Mansukhani, MDTaking people
- Cleveland Clinic FoundationCleveland, United StatesContact: Francis Caputo, MDTaking people
- UT SouthwesternDallas, United StatesContact: Mirza Baig, MDTaking people
- University of Florida Shands HospitalGainesville, United StatesContact: Zain Shahid, MDTaking people
- Endeavor Health Cardiovascular Institute at Glenbrook HospitalGlenview, United StatesContact: George PontikisTaking people
- Memorial Hermann Texas Medical Center UT HealthHouston, United StatesContact: Naveed Saqib, MDTaking people
- Methodist Hospital of IndianaIndianapolis, United StatesContact: Andres Fajardo, MDTaking people
- Holston Valley HospitalKingsport, United StatesContact: Robert "Bo" Allen, MDTaking people
- UC San DiegoLa Jolla, United StatesContact: Mahmoud Malas, MDTaking people
- Dartmouth Hitchcock Medical CenterLebanon, United StatesContact: Bjoern Suckow, MDTaking people
- University of Southern CaliforniaLos Angeles, United StatesContact: Sukgu Han, MDTaking people
- Loyola University Medical CenterMaywood, United StatesContact: Michael Soult, MDTaking people
- Edward HospitalNaperville, United StatesContact: George Pontikis, MDTaking people
- Columbia University Irving Medical Center/NY Presbyterian HospitalNew York, United StatesContact: Virenda PatelTaking people
- New York University Langone Medical CenterNew York, United StatesContact: Thomas Maldonado, MDTaking people
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesContact: Grace Wang, MDTaking people
- University of Pittsburgh Medical CenterPittsburgh, United StatesContact: Nathan LiangTaking people
- Carilion Roanoke Memorial HospitalRoanoke, United StatesContact: Chanda Bell, RN, BSNNo longer taking part
- Mayo ClinicRochester, United StatesContact: Randall DeMartino, MDTaking people
- Barnes-Jewish HospitalSt Louis, United StatesContact: John Ohman, MDTaking people
- Stanford Hospitals and ClinicsStanford, United StatesContact: Jason Lee, MDTaking people
- Tampa General HospitalTampa, United StatesContact: Dean Arnaoutakis, MDTaking people
- MedStar Washington Hospital CenterWashington D.C., United StatesContact: Steven Abramowitz, MDTaking people
- University of MassachusettsWorcester, United StatesContact: Andres Schanzer, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
Up to 130 additional subjects may be enrolled in Continued Access phase of the study
The group in the trial
- Aortic abdominal aneurysmTreatment being tested
Treatment: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Zenith® Fenestrated+ Endovascular Graft Clinical Study
- Plain-language title
- Stent graft device for aortic aneurysms near the kidney arteriesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 6 October 2026