Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-Branched Endovascular Aortic Repair: A Ten-year Experience.
Thomas Mesnard, Ying Huang, Andres Schanzer...
https://pubmed.ncbi.nlm.nih.gov/39963789Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02043691
Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch Pathologies Using Cook Custom Aortic Endografts, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endograft
Led by University of Alabama at Birmingham · Updated on 2026-01-06
410
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
C
Cook Group Incorporated
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of three investigational devices—the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts—in treating complex aortic conditions such as juxtarenal, suprarenal, thoracoabdominal, and aortic arch pathologies that involve at least one brachiocephalic artery or visceral vessels. These devices provide a customized endovascular approach aimed at addressing conditions not treatable with commercially available devices and may reduce hospital stays and complications. Participants will receive one of the three investigational devices based on their specific condition. The Cook Custom Aortic Endograft is designed with up to five fenestrations and/or branches to seal and fix the device around affected areas. The Zenith t-Branch Endovascular Graft features four branches connected to key arteries with self-expanding stents. Surgeon-Modified Endografts are created during surgery by adapting existing devices to fit the patient's anatomy. Before treatment, participants undergo exams, blood tests, CT scans, X-rays, angiography, and other assessments depending on the aortic pathology. Participants will be followed for five years with regular clinical exams, imaging, neurological assessments, and blood tests to monitor device performance and safety. Researchers will track major adverse events within 30 days post-procedure and monitor mortality rates, pulmonary complications, neurologic morbidity, device integrity, and need for further interventions at multiple time points up to five years. This comprehensive follow-up helps assess the long-term effects and success of these investigational devices in treating complex aortic diseases.
CONDITIONS
Brief Title
Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Juxtarenal, suprarenal, or thoracoabdominal aortic pathology with stable hemodynamics
- Aneurysms involving or near the visceral segment of the aorta with specific size or growth criteria
- Penetrating aortic ulcer larger than 2.0 cm in depth or symptomatic/ruptured
- Subacute or chronic aortic dissection with aneurysmal changes meeting size or symptom criteria
- Aortic arch pathology such as aneurysm, pseudoaneurysm, or specific dissections
- Suitable iliac and brachial artery access for device delivery
- Target arteries with adequate size, sealing zones, and absence of severe tortuosity or dissection
- Ability to provide informed consent and comply with follow-up
You will not qualify if you...
- Under 18 years of age
- Life expectancy less than 12 months
- Pregnant, breastfeeding, or planning pregnancy within 60 months
- Unable or unwilling to give informed consent or comply with follow-up
- Participation in another investigational drug or device study within 30 days
- Allergy to device components such as stainless steel, polyester, gold, or nitinol
- History of severe allergic reaction to contrast material not manageable with premedication
- Active systemic or local infection increasing graft infection risk
- Severe kidney impairment with eGFR below 30 mL/min unless on or planning dialysis
- Body habitus preventing X-ray visualization of the aorta
- Recent major surgery unrelated to aneurysm repair within 30 days
- Unstable angina or irreversible blood clotting disorders
- Aortic trauma or infectious aortic disease
- Significant vessel disease or anatomy preventing device delivery or fixation
- Inadequate landing zones or vessel sizes outside specified ranges
- Untreatable branch vessel stenosis or anatomy unsuitable for device implantation
- Patients eligible for similar industry-sponsored studies allowing alternative repair
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Implementation
Duration - Procedure day and immediate recovery
Participants undergo placement of one of the aortic endografts (Cook Custom Aortic Endograft, Zenith t-Branch Endovascular Graft, or Surgeon-Modified Endograft) designed to treat their aortic pathology. This includes graft design or sizing based on clinical exams, imaging, and angiography performed during screening.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 5 years
Participants are monitored for safety and efficacy outcomes including survival, pulmonary morbidity, device integrity, and need for reintervention after the endograft placement.
Multiple follow-up visits through 5 years after procedure
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
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Research Team
A
Adam W Beck, MD
R
Rebecca St John
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study.
Gustavo S Oderich, Ying Huang, William S Harmsen...
https://pubmed.ncbi.nlm.nih.gov/38989575Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair.
Eric J Finnesgard, Adam W Beck, Matthew J Eagleton...
https://pubmed.ncbi.nlm.nih.gov/37330702Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium.
Victoria J Aucoin, Claire M Motyl, Zdenek Novak...
https://pubmed.ncbi.nlm.nih.gov/37059239