Zenith® Fenestrated+ Clinical Study

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04875429
• Other study ID #: 17-07
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: April 2031

Study information

• Verified date: April 2024
• Source: Cook Group Incorporated
• Contact: Chanda Bell, RN, BSN
• Phone: 765-463-7537
• Email: chanda.bell[@]cookmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: April 2031
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Juxtarenal Aortic Aneurysm
• Pararenal Aneurysm

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ut Southwestern	Dallas	Texas
United States	University of Florida Shands Hospital	Gainesville	Florida
United States	Memorial Hermann Texas Medical Center/UT Health	Houston	Texas
United States	UC San Diego	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Southern California	Los Angeles	California
United States	New York University Langone Medical Center	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	Stanford Hospitals and Clinics	Stanford	California
United States	Tampa General Hospital	Tampa	Florida
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite measure of device technical success and procedural safety	Percent of patients with device technical success and freedom from procedural safety events in the following criteria: Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and; Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke	30 days post procedure
Primary	Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention	Percent of patients meeting the following criteria: Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and; Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)	12 months post procedure