Active not recruitingOBSERVATIONAL

Registry in Patients With Aorto-iliac or Iliac Aneurysms

This study, called PLIANT II, is observing how well a medical device, the E-liac Stent Graft System, works for patients who have a condition called an aneurysm in their main blood vessel (aorta) or leg arteries (iliac arteries). An aneurysm is essentially a bulge in a blood vessel wall. Doctors will use this device if they think it's the best treatment for their patients. The study aims to gather information on how these patients do over time in normal healthcare settings, rather than a controlled lab environment. This helps doctors understand the device's real-world effectiveness and safety. Patients will be asked to give permission for their health information to be used for this study.

At a glance

Status

Active not recruiting

Sponsor

JOTEC GmbH

Enrolment target

298

Start

15 Jul 2018

Estimated completion

31 Oct 2029

Vascular Aneurysm

What is this study about?

This study is called PLIANT II and it's looking at a treatment for a condition called an aneurysm. An aneurysm is like a weak spot or bulge in a blood vessel, which can be found in your body's main artery (the aorta) or in the arteries that go to your legs (iliac arteries). Doctors sometimes treat these bulges with a special tube-like device called a stent graft. In this study, they are specifically looking at a device called the E-liac Stent Graft System.

Think of this study as a way for doctors to learn more about how this particular stent graft works for patients in everyday hospital and clinic settings. It's not a trial where people are randomly given different treatments; instead, doctors are using their best judgment to decide if the E-liac Stent Graft System is the right treatment for their patients. They then keep track of how those patients are doing after the treatment.

The main goal is to carefully watch patients who receive this treatment and collect information about their health outcomes over five years. This helps medical experts understand how effective and safe the E-liac Stent Graft System is over a longer period, using information gathered from real patients receiving their usual care. Your doctor will need your permission to share your health records for this study.

Key takeaways

This study observes how the E-liac Stent Graft System works for patients with aneurysms.
It collects information during your regular medical care, not through extra tests.
The study lasts for up to five years, from the time of your procedure.
Your doctor decides if the E-liac Stent Graft is the right treatment for you.
You must give permission for your health information to be used for the study.
You are aged between 18 and 85 years old.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 85 years old. You must have an aneurysm in your aorta or iliac arteries, and your doctors must decide that your body is suitable for placing the special E-liac Stent Graft. You also need to be able to attend follow-up appointments as required throughout the study, which will last for five years, and agree for your health information to be used for research.

There are certain reasons why you might not be able to join. For example, if you are a woman who could become pregnant, or if your aneurysm has already burst, you wouldn't be able to take part. Also, if your aneurysm is located very high up near your kidneys, or if you're currently in another medical study that might affect this one, you wouldn't be eligible. Patients with certain serious illnesses like cancer requiring treatment, or those with a predicted life expectancy of less than three years, would also not be able to participate. This study is only for adults, so minors or individuals under guardianship cannot join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am between 18 and 85 years old.
I have an aneurysm in my aorta or iliac artery.
My doctor has determined my aneurysm is suitable for stent graft placement.
I can attend regular follow-up appointments for five years.
I am not currently pregnant or able to become pregnant (for women).
My aneurysm hasn't burst.

Answer every question to see your result.

What does participation involve?

If you join this study, it means your doctors will use the E-liac Stent Graft System to treat your aneurysm, as they've decided it's the best option for you. After the procedure, your doctors will simply track your health and recovery as part of your normal check-ups and follow-up appointments. They will collect information from these routine visits for the study.

The study aims to collect this information over a period of 60 months (5 years) starting from the day you have your procedure. During this time, you won't be asked to do anything extra beyond your usual medical care. The information collected will be based on your routine observations by medical staff.

Potential risks and benefits

The potential benefits of participating mean that if your doctor decides the E-liac Stent Graft System is the best treatment for your aneurysm, you would receive this treatment and your progress would be carefully monitored as part of your standard care. The study aims to gather important information that could help future patients. As this is an observational study of a treatment your doctor has already decided upon, the immediate risks are those associated with the E-liac Stent Graft procedure itself and not specific to the study's research aspect. You always have the right to withdraw your consent for your data to be used in the study at any time, without affecting your medical care.

Locations (1)

Universitätsklinikum Köln
Verified postcode
Cologne, Germany

Common questions

What is an aneurysm?

An aneurysm is a weak spot in a blood vessel that bulges out, like a bubble on a pipe. It often occurs in the main artery of your body (aorta) or in arteries in your legs (iliac arteries).

What is the E-liac Stent Graft System?

It's a special tube-like device that doctors use to strengthen a weak blood vessel (aneurysm) by placing it inside the vessel to redirect blood flow and prevent the bulge from growing or bursting.

Will I have extra doctor visits if I join this study?

No, you won't have extra visits. The study gathers information from your regular, routine check-ups and follow-up appointments that your doctor would schedule anyway as part of your treatment.

How long will the study follow me?

The study will collect information about your health for up to five years (60 months) from the time you have the stent graft placed.

Can I leave the study if I change my mind?

Yes, you can withdraw your permission for your health information to be used in the study at any time. This will not affect the medical care you receive.