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Evaluation of a new endovascular graft for treating aortic aneurysms

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Not applicable Interventional Cook Group Incorporated · NCT04875429

This study is testing a new type of graft to see if it can safely and effectively treat aortic aneurysms in patients with specific conditions affecting their major arteries.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment105 (estimated)
Ages18 Years and up
SexAll
SponsorCook Group Incorporated Industry-sponsored
Locations33 sites (Birmingham, Alabama and 32 other locations)
Trial IDNCT04875429 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 for patients with aortic aneurysms affecting major visceral arteries. The study focuses on patients with thoracoabdominal, pararenal, or juxtarenal aortic aneurysms that meet specific size and growth criteria. Participants will be monitored for outcomes related to the treatment's efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates are adults with thoracoabdominal, pararenal, or juxtarenal aortic aneurysms measuring 55 mm or more in diameter for males and 50 mm or more for females.

Not a fit: Patients under 18 years old, those with a life expectancy of less than 2 years, or individuals who are pregnant or breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for managing complex aortic aneurysms, potentially reducing the need for open surgery.

How similar studies have performed: Previous studies involving similar endovascular graft technologies have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Include Criteria:

1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females
2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
3. 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

Exclusion Criteria:

1. Age \< 18 years
2. Life expectancy \< 2 years
3. Pregnant, breast-feeding, or planning to become pregnant within 60 months
4. Inability or refusal to give informed consent by the patient or legally authorized representative
5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

Where this trial is running

Birmingham, Alabama and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic Aneurysm, AbdominalJuxtarenal Aortic AneurysmExtent IV ThoracoabdominalPararenal AneurysmendovascularVascular DiseasesCardiovascular DiseasesFenestration
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.