Zenith® Fenestrated+ Clinical Study

Sponsor

Cook Research Incorporated (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04875429

Collaborator

(none)

102

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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 (BGUS) for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal Juxtarenal Aortic Aneurysm Extent IV Thoracoabdominal Pararenal Aneurysm	Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aortic abdominal aneurysm	Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System Endovascular aneurysm repair

Arm

Intervention/Treatment

Experimental: Aortic abdominal aneurysm

Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System

Endovascular aneurysm repair

Outcome Measures

Primary Outcome Measures

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: 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
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention [12 months post procedure]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Include Criteria:

Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
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:

Age < 18 years
Life expectancy < 2 years
Pregnant, breast-feeding, or planning to become pregnant within 60 months
Inability or refusal to give informed consent by the patient or legally authorized representative
Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study