Zenith® Fenestrated+ Clinical Study

Launched by COOK RESEARCH INCORPORATED · May 4, 2021

Keywords

ClinConnect Summary

The Zenith® Fenestrated+ Clinical Study is a research trial looking at a new treatment option for patients with certain types of aortic aneurysms, which are bulges in the main artery of the body. The study is testing a special device called the Zenith® Fenestrated+ Endovascular Graft, used together with another device called the BeGraft Balloon-Expandable Stent. The goal is to see if these devices are safe and effective for patients whose aneurysms are near important arteries.

To be eligible for this study, participants should be between 65 and 74 years old and have a specific type of aortic aneurysm that is larger than 55 mm for men or 50 mm for women, or that is growing quickly. Participants should expect to be closely monitored and will need to attend follow-up appointments to check on their health after the procedure. It's important to know that this trial is currently recruiting patients, and those who are interested will need to provide informed consent and meet other specific criteria to participate.

Gender

ALL

Eligibility 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