Zenith® Fenestrated+ Clinical Study

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.

Up to 60 additional subjects may be enrolled in Continued Access phase of the study

Recruiting

Interested in participating?

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Key information

Conditions

Aortic Aneurysm, Abdominal Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Extent IV Thoracoabdominal Juxtarenal Aortic Aneurysm Pararenal Aneurysm Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Thomas' Hospital, London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Include Criteria:

Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females
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

Treatment and study plan

Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2

Device

Endovascular aneurysm repair

Primary outcomes

Composite measure of device technical success and procedural safety

Time frame: 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

Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chanda Bell, RN, BSN

CONTACT

[email protected]

765-463-7537 ext. 321506

Maria Soerensen

CONTACT

[email protected]

+45 2868 3248

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2031
First posted: May 6, 2021
Registry last updated: Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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