Zenith® Fenestrated+ Endovascular Clinical Study

Overview

About this study

The primary objective of this study is to evaluate the safety and effectiveness of the Zenith® Fenestrated+Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) for the treatment of patients with aortic aneurysms, where the device sealing zone requires fenestrations with connections to one or more of the major
visceral arteries.
Secondary outcomes, evaluated for descriptive purposes (not for statistical inference) include the assessment of procedural variables and clinical utility measures (see secondary outcomes).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Include Criteria:

1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/10/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Bernardo Mendes, M.D.	Open for enrollment	Contact information: Danielle Hoffman CPT(NHA) (507) 538-5063 Hoffman.Danielle@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bernardo Mendes, M.D.

Open for enrollment

Contact information:

Danielle Hoffman CPT(NHA)

(507) 538-5063

Hoffman.Danielle@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials