Zenith® Fenestrated+ Clinical Study

Not Applicable

Recruiting

• Conditions: Extent IV Thoracoabdominal; Aortic Aneurysm, Abdominal; Juxtarenal Aortic Aneurysm; Pararenal Aneurysm

• Registration Number: NCT04875429
• Lead Sponsor: Cook Research Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-06
• Study Start: 2023-12-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-15
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-06
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite measure of device technical success and procedural safety	30 days post procedure	Percent of patients with device technical success and freedom from procedural safety events in the following criteria: 1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and; 2. 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
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention	12 months post procedure	Percent of patients meeting the following criteria: 1. 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; 2. 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)

Trial Locations

Locations (32)

University of Alabama Birmingham Hospital; 🇺🇸 Birmingham, Alabama, United States

UC San Diego; 🇺🇸 La Jolla, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Stanford Hospitals and Clinics; 🇺🇸 Stanford, California, United States

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida Shands Hospital; 🇺🇸 Gainesville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

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