Fenestrated Stent Graft for Abdominal Aortic Aneurysm
(IDE#1 Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byGustavo Oderich, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Under 18, Pregnant, Life expectancy < 2 years, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Fenestrated Stent Graft for Abdominal Aortic Aneurysm?
The Zenith Fenestrated Endovascular Graft (ZFEN) is associated with lower short-term complications and death rates compared to traditional open surgery for complex abdominal aortic aneurysms. Additionally, a case study showed successful treatment of a complex aneurysm with no complications after one year.12345
Is the Fenestrated Stent Graft for Abdominal Aortic Aneurysm safe for humans?
What makes the Zenith Fenestrated AAA Endovascular Graft treatment unique for abdominal aortic aneurysm?
The Zenith Fenestrated AAA Endovascular Graft is unique because it is a custom-made device designed to fit the specific anatomy of each patient, allowing it to treat complex abdominal aortic aneurysms that are close to the renal arteries. This personalized approach can reduce the risk of complications and improve outcomes compared to traditional open surgery.12348
Eligibility Criteria
This trial is for adults with complex abdominal aortic aneurysms, specifically juxtarenal, suprarenal, or type IV thoracoabdominal types that are at high risk of rupture. Candidates should have aneurysms ≥5.0 cm or twice the normal size, or those growing ≥0.5 cm per year. Excluded are individuals under 18, pregnant/breastfeeding women, those unwilling to follow up, with less than 2 years life expectancy or other medical/anatomical restrictions.Inclusion Criteria
My aneurysm has grown at least 0.5 cm in a year.
I have a large aneurysm near my kidney or chest suitable for a specific graft treatment.
My doctor thinks my aneurysm is at high risk of bursting.
Exclusion Criteria
You are not expected to live for more than 2 years.
Additional anatomical restrictions as specified in the Clinical Investigation Plan
I am under 18 years old.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo endovascular aortic repair using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft
6 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of major adverse events and treatment success
12 months
Multiple visits (in-person and virtual)
Long-term Follow-up
Participants' quality of life is assessed using the SF-36 questionnaire over several years
5 years
Annual visits (in-person or virtual)
Treatment Details
Interventions
- Custom-made Zenith® Fenestrated AAA Endovascular Graft (Stent Graft)
Trial OverviewThe study tests the effectiveness and quality of life impact of using custom-made Cook Zenith® Fenestrated AAA Endovascular Grafts in repairing complex abdominal aortic aneurysms close to the kidneys and above.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EndovascularExperimental Treatment1 Intervention
The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
Other names:
Endovascular stent Stent-graft
Custom-made Zenith® Fenestrated AAA Endovascular Graft is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Zenith Fenestrated AAA Endovascular Graft for:
- Infrarenal abdominal aortic aneurysms (AAAs) in high-risk patients who are not suitable for conventional open surgical repair or who are not suitable for repair with a standard Zenith Endovascular Graft, when the aneurysmal disease extends up to the level of the renal arteries.
🇪🇺 Approved in European Union as Zenith Fenestrated AAA Endovascular Graft for:
- Infrarenal abdominal aortic aneurysms (AAAs) in high-risk patients who are not suitable for conventional open surgical repair or who are not suitable for repair with a standard Zenith Endovascular Graft, when the aneurysmal disease extends up to the level of the renal arteries.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
Mayo ClinicRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
Gustavo OderichLead Sponsor
Cook Group IncorporatedIndustry Sponsor
References
Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States. [2019]Fenestrated endografts are customized, patient-specific, endovascular devices with potential to significantly reduce morbidity and mortality of short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair. The Zenith fenestrated endovascular graft (ZFEN) for abdominal aortic aneurysms (Cook Medical, Bloomington, Ind), Food and Drug Administration-approved in 2012, remains the only fenestrated device available in the United States. This technology is among the most technically complex catheter-based procedures and, therefore, inherently associated with serious risk for device-related complications. We sought to define patterns of physician and hospital adoption of ZFEN.
Fenestrated endovascular aneurysm repair is associated with lower perioperative morbidity and mortality compared with open repair for complex abdominal aortic aneurysms. [2019]The Zenith Fenestrated Endovascular Graft (ZFEN; Cook Medical, Bloomington, Ind) has expanded the anatomic eligibility of endovascular aneurysm repair (EVAR) for complex abdominal aortic aneurysms (AAAs). Current data on ZFEN mainly consist of single-institution experiences and show conflicting results. Therefore, we compared perioperative outcomes after repair using ZFEN with open complex AAA repair and infrarenal EVAR in a nationwide multicenter registry.
Maximizing proximal seal zone in fenestrated endografting: Evolution in the approach to graft configuration. [2021]Fenestrated endografting for juxtarenal and pararenal abdominal aortic aneurysms affords the ability to seal stent grafts in normal aorta at and above the renal arteries. The Zenith fenestrated graft (ZFEN; Cook Medical, Bloomington, Ind) is custom-made to surgeon specifications, subject to certain manufacturing limitations. The most common configuration in the pivotal trial and in commercial use after approval has been as a scallop for the superior mesenteric artery (SMA) and two small fenestrations for the renal arteries (configuration A). An alternative configuration to maximize the seal zone length, consisting of a large fenestration for the SMA and two small fenestrations for the renal arteries (configuration B) has been routinely adopted at our institutions to potentially prevent type IA endoleak.
Technical aspects of repair of juxtarenal abdominal aortic aneurysms using the Zenith fenestrated endovascular stent graft. [2016]Fenestrated endovascular aortic repair has been used with increasing frequency to treat complex aortic aneurysms. The Zenith fenestrated stent graft system (Cook Medical Inc, Brisbane, Queensland, Australia) was approved for commercial use in the United States in April 2012, offering a custom-made design with up to three fenestrations to treat short-neck infrarenal and juxtarenal abdominal aortic aneurysms. This report and the Video presentation (online only) summarize the preoperative planning, stent graft design, and technique of implantation of a Zenith fenestrated stent graft using a totally percutaneous approach in an 80-year-old female patient with a 6-cm juxtarenal abdominal aortic aneurysm. The patient was dismissed home the next day without complications, and a computed tomography angiography at 12 months showed no endoleak or stent graft complications.
Practice Patterns of Fenestrated Aortic Aneurysm Repair: Nationwide Comparison of Z-Fen Adoption at Academic and Community Centers Since Commercial Availability. [2018]Over the past decade, a number of endovascular approaches have evolved to treat aortic aneurysms with anatomy that is not amenable to traditional endovascular repair, although the optimal practice and referral patterns remain in question. The Zenith fenestrated (Z-Fen) endograft (Cook Medical) represents the first commercially available fenestrated graft product in the United States.
Superior mesenteric artery outcomes after large fenestration strut relocation with the Zenith Fenestrated endoprosthesis. [2020]The Zenith® Fenestrated (ZFen) stent-graft is frequently configured with a strut-spanning large fenestration for superior mesenteric artery (SMA) incorporation. This has led some to relocate struts to create a strut-free fenestration and place a bridging stent. The aim of this study was to compare SMA outcomes with and without large fenestration strut relocation.
Results of the United States multicenter prospective study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal aortic aneurysms. [2014]This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the Zenith fenestrated endovascular graft (Cook Medical, Bloomington, Ind) for treatment of juxtarenal abdominal aortic aneurysms (AAAs).
Outcomes of fenestrated endografts in the treatment of abdominal aortic aneurysm in Western Australia (1997-2004). [2022]To describe a 7-year experience with abdominal aortic aneurysm (AAA) repair using fenestrated Zenith endovascular endografts.