Purpose

The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Aortic abdominal aneurysm
  • Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
    Endovascular aneurysm repair

Recruiting Locations

Medstar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Javairiah Fatima, MD

More Details

Status
Recruiting
Sponsor
Cook Research Incorporated

Study Contact

Chanda Bell, RN, BSN
765-463-7537
chanda.bell@cookmedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.