Active not recruitingOBSERVATIONAL

Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection

This project is gathering information about a medical device called the AMDS (Ascyrus Medical Dissection Stent). It's for people who have a condition called acute aortic dissection, which is a tear in the body's main artery. Normally, blood flows through one main channel in this artery. But with a dissection, a second channel forms, and blood flows through both. The AMDS stent is a small metal tube placed in the artery to help keep the main channel open. This study isn't testing a new treatment; it's simply collecting details from patients who have already had the AMDS stent as part of their regular hospital care. The aim is to understand how well the stent works and if it helps people get better.

At a glance

Status

Active not recruiting

Sponsor

JOTEC GmbH

Enrolment target

301

Start

12 Mar 2019

Estimated completion

30 Jun 2030

Aortic Dissection Acute DeBakey I Dissection Acute Type A Dissection Intramural Hematoma

What is this study about?

Imagine your body's main blood vessel, called the aorta, like a garden hose. Normally, water (blood) flows smoothly through the middle of the hose. In people with a serious condition called an acute aortic dissection, the inner layer of the hose wall rips, and blood can then flow into this tear, creating a new, incorrect channel next to the main one. This can be very dangerous.

Doctors sometimes treat this condition with a special tube called the AMDS stent. This stent is a small, flexible mesh tube that is placed inside the part of the aorta that goes down through your chest. Its job is to help support the main channel, so blood flows correctly. This study is collecting information about how well this stent works in real-life situations.

This isn't a study where doctors are trying out a new treatment. Instead, it's about observing patients who have already received the AMDS stent as part of their standard medical care. Doctors will share information they have collected about these patients during their normal check-ups. This helps researchers learn more about the stent's benefits and how patients are doing after getting it. The goal is to gather important information to help doctors understand the best ways to treat this condition.

Key takeaways

This study collects information about how a device called the AMDS stent works for people with a serious heart condition.
It's for patients who have already received the AMDS stent as part of their standard hospital care.
Participation means allowing researchers to use your existing medical information.
You won't have any extra procedures or appointments because of this study.
The aim is to learn more about the stent's benefits to help future patients.

Who may be eligible?

To be considered for this study, you would need to be between 18 and 80 years old. You must have been diagnosed with a specific type of aortic dissection, called acute DeBakey Type I dissection, or a related condition called intramural hematoma, within the last 14 days. These conditions are usually found using a special type of X-ray called a CT scan.

There are also reasons you might not be able to join. For example, if you are under 18 or over 80, or if you have a serious ongoing infection. You also wouldn't be able to participate if you have severe allergies to certain medical materials or dyes used in scans. If you were in a coma before your surgery or had a very severe, life-threatening emergency requiring CPR, you would also not be eligible.

Finally, the study wouldn't be suitable if your aorta has certain specific problems with its shape or if the tear is older than 14 days. You also need to be willing to come for follow-up appointments and give your permission for your medical information to be used in the study.

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.

Are you between 18 and 80 years old?
Have you been diagnosed with acute DeBakey Type I aortic dissection or intramural hematoma in the last 14 days?
Are you willing to attend your regular follow-up appointments?
Are you willing to let your medical records be used for research?

Answer every question to see your result.

What does participation involve?

If you take part in this registry, it means that your medical information, which doctors collect during your normal hospital visits and follow-up appointments, will be shared with the study. You won't receive any new treatments or extra tests specifically for this study. The AMDS stent would have already been implanted as part of your standard care, if your doctor decided it was the right treatment for you.

Doctors will simply record their observations from your regular check-ups. The main thing you would do for the study is to give your permission for your health records to be used. This study is observational, meaning researchers are just looking at information that's already being gathered. The total duration of follow-up varies depending on your individual treatment plan, but the information will be collected from your existing medical records.

Potential risks and benefits

Since this is an observational study, you will not undergo any additional procedures or treatments as part of the research itself, beyond what your doctor has already decided is best for your care. Therefore, there are no direct extra risks from participating in the study. The potential benefit is that by allowing your de-identified medical information to be included, you contribute to a better understanding of how the AMDS stent works, which could help improve care for future patients with similar conditions. You always have the right to withdraw your consent for your data to be used at any time.

Locations (1)

Deutsches Herzzentrum der Charité
Verified postcode
Berlin, Germany

Common questions

What is an aortic dissection?

It's a serious condition where the main blood vessel from your heart, the aorta, gets a tear in its inner lining, allowing blood to flow between the layers of the wall.

What is the AMDS stent?

It's a small, flexible metal tube that doctors place inside the aorta to help keep the main blood channel open after a dissection.

Will I get this stent if I join the study?

No, this study is for people who have already had the AMDS stent implanted as part of their regular medical care. The study is collecting information about how well it worked for them.

What will I have to do if I take part?

You'll be asked to give your permission for your doctors to share information from your medical records. You won't have any extra appointments or treatments because of the study.

Are there any risks to joining this study?

Not directly from the study itself, because it only involves collecting information from your existing medical records. You won't have any extra procedures or tests.