Zenith® Fenestrated+ Clinical Study
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
- Aortic Aneurysm, Abdominal
- Juxtarenal Aortic Aneurysm
- Extent IV Thoracoabdominal
- Pararenal Aneurysm
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Aortic abdominal aneurysm |
|
Recruiting Locations
Washington, District of Columbia 20010
Javairiah Fatima, MD
More Details
- Status
- Recruiting
- Sponsor
- Cook Research Incorporated