RecruitingNAINTERVENTIONAL

Zenith® Fenestrated+ Clinical Study

This study, called Zenith® Fenestrated+ Clinical Study, is testing a new treatment for serious swellings (aneurysms) in the body's main blood vessel, the aorta. Specifically, it focuses on aneurysms located near the kidneys or extending into the chest. The treatment involves a special stent graft system, which is a tube-like device placed inside the blood vessel, along with additional support devices. The main goal is to check how safe this new method is and how well it works to treat these aneurysms. This trial is for adult patients (18 and over) and aims to provide a gentler way to manage these complex conditions, potentially improving patient outcomes.

At a glance

Status

Recruiting

Phase

Sponsor

Cook Research Incorporated

Enrolment target

105

Start

08 Dec 2023

Estimated completion

01 Nov 2031

Aortic Aneurysm, Abdominal Juxtarenal Aortic Aneurysm Extent IV Thoracoabdominal Pararenal Aneurysm

What is this study about?

This clinical study is investigating a new way to treat a serious condition called an aortic aneurysm. An aortic aneurysm is essentially a dangerous bulge or swelling in the aorta, which is the largest blood vessel in your body. It carries blood from your heart to the rest of your body. When these aneurysms occur near your kidneys or stretch up towards your chest, they are particularly complex to treat.

The treatment being studied involves a special type of 'stent graft'. Think of a stent graft as a reinforced tube that is carefully placed inside your aorta to strengthen the weakened area and prevent the aneurysm from bursting. This particular system, called the Zenith® Fenestrated+ Endovascular Graft, works with other devices to tailor the treatment specifically to the individual shape of your aneurysm, especially when it involves important branching arteries that go to your kidneys or other organs.

The aim of this study is to thoroughly check if this new combination of devices is safe for patients and if it effectively treats these aneurysms. By participating, patients are helping doctors understand if this less invasive approach can be a good option for treating these challenging aortic conditions, ultimately hoping to improve the lives of people affected by them.

Key takeaways

This study is testing a new stent graft treatment for complex aortic aneurysms.
It aims to find out if the treatment is safe and effective.
Participation involves a surgical procedure and regular follow-up appointments.
It's for adults with specific types and sizes of aortic aneurysms.
You can withdraw from the study at any time.
The treatment is being carefully evaluated to improve patient care.

Who may be eligible?

This study is open to adults aged 18 and older. You might be suitable if you have a specific type of aneurysm in your aorta, near your kidneys or extending into your chest, that meets certain size requirements (e.g., at least 55mm for men, 50mm for women). Also, if your aneurysm has grown quickly in a short period, or if your doctor believes it needs treatment, you could be considered.

However, some people won't be able to join. This includes if you're under 18, if your doctor believes you have less than two years to live, if you are pregnant, breastfeeding, or planning to become pregnant within the next five years. You also need to be able to understand the study and agree to participate, as well as commit to the follow-up appointments and scans.

Quick self-check

Are you 18 years old or older?
Do you have an aneurysm in your aorta near your kidneys or chest?
Is your aneurysm a certain size (e.g., 55mm for men, 50mm for women)?
Are you able to attend all required follow-up appointments and scans?
Are you not pregnant or planning a pregnancy in the next five years?
Do you understand what the study involves and agree to participate?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will undergo the new treatment involving the Zenith® Fenestrated+ Endovascular Graft. This is a surgical procedure. After the procedure, you will need to attend regular follow-up appointments, which will include clinical assessments (check-ups) and imaging scans (like CT scans) to monitor your recovery and the success of the treatment. The exact number and timing of these appointments will be clearly explained by the study team. You will not be given any additional medication specifically for the study, beyond what is part of your standard medical care.

The study team will monitor your progress closely over a period of time to ensure the treatment is safe and effective. The total duration of your participation in the study, including all follow-up, will be clearly outlined to you before you agree to take part. It's important to understand that your commitment to these follow-up visits is vital for the success of the study.

Potential risks and benefits

Like any medical procedure, there are potential benefits and risks to consider. The potential benefit of taking part is that you would receive a new, potentially less invasive treatment for a serious aortic aneurysm, which could improve your health and quality of life. However, as this is a new treatment being studied, there are unknown risks, and the procedure itself carries risks inherent to any surgery, including infection, bleeding, or complications from the device. The medical team will explain all known risks to you in detail. It's very important to remember that participating in the study is entirely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (33)

University of Alabama Birmingham Hospital
Birmingham, United States· Recruiting
UC San Diego
La Jolla, United States· Recruiting
University of Southern California
Los Angeles, United States· Recruiting
Stanford Hospitals and Clinics
Stanford, United States· Recruiting
Medstar Washington Hospital Center
Washington D.C., United States· Recruiting
University of Florida Shands Hospital
Gainesville, United States· Recruiting
Tampa General Hospital
Tampa, United States· Recruiting
Emory University Hospital
Atlanta, United States· Recruiting
Northwestern Memorial Hospital
Chicago, United States· Recruiting
Endeavor Health Cardiovascular Institute at Glenbrook Hospital
Glenview, United States· Recruiting
Loyola University Medical Center
Maywood, United States· Recruiting
Edward Hospital
Naperville, United States· Recruiting

+21 more sites — see the official record for the full list.

Common questions

What is an aortic aneurysm?

It's a dangerous bulge or swelling in your aorta, the body's main blood vessel, which can be serious if not treated.

What is a 'stent graft'?

It's a tube-like device placed inside the blood vessel to strengthen the weakened area and prevent the aneurysm from bursting.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatment or assessments. Your regular care might incur standard NHS charges.

What happens if I change my mind?

You can withdraw from the study at any time, for any reason, without affecting your future medical care.

What does 'fenestrated' mean in the treatment name?

It means the stent graft has special openings that allow blood to reach important arteries branching off the aorta, such as those going to your kidneys.

How to find out more

Chanda Bell, RN, BSN

chanda.bell@cookmedical.com 765-463-7537 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.