RecruitingNot Applicable

Zenith® Fenestrated+ Clinical Study

United States, United Kingdom105 participantsStarted 2023-12-08

Plain-language 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. Up to 60 additional subjects may be enrolled in Continued Access phase of the study

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite measure of device technical success and procedural safety

Timeframe: 30 days post procedure

Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention

Timeframe: 12 months post procedure

Trial details

NCT IDNCT04875429

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Chanda Bell, RN, BSN

765-463-7537 chanda.bell@cookmedical.com

View on ClinicalTrials.gov More Aortic Aneurysm, Abdominal trials