Active not recruitingOBSERVATIONAL

Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)

This study, called STABILISE, is a registry — like a collection of records — for patients with a specific heart condition called Type B aortic dissection. This condition involves a tear in the body's main blood vessel, the aorta. The study aims to see how well a treatment called the STABILISE technique works for people with recent Type B aortic dissection (either acute or subacute). Researchers will collect information on patients who have this treatment, carefully noting their results and any events that happen after the procedure. This helps medical professionals understand the effectiveness and safety of the STABILISE technique in real-world settings, following specific reporting rules to ensure clear and consistent information.

At a glance

Status

Active not recruiting

Sponsor

IRCCS San Raffaele

Enrolment target

200

Start

30 Oct 2018

Estimated completion

30 Dec 2026

Aortic Dissection

What is this study about?

This study is gathering information about a serious heart condition affecting the body's largest blood vessel, the aorta. This vessel carries blood from your heart to the rest of your body. Sometimes, the layers of the aorta can tear, creating a condition called aortic dissection. This particular study focuses on 'Type B' aortic dissection, which affects a specific part of this important blood vessel.

The study is interested in how well a treatment called the STABILISE technique works for people who have recently experienced a Type B aortic dissection. 'Acute' means it happened up to two weeks ago, and 'subacute' means it happened between three and twelve weeks ago. The STABILISE technique is a medical procedure used to help repair the aorta.

By collecting detailed information from patients undergoing this treatment, the researchers hope to understand its outcomes better. This includes looking at how well patients recover and if there are any issues after the procedure. The goal is to provide clear and consistent reports, helping doctors decide the best way to treat this condition in the future.

Key takeaways

This study is about a heart condition called Type B aortic dissection.
It collects information about a treatment called the STABILISE technique.
The aim is to see how well the STABILISE technique helps patients.
Participation means your medical details about this treatment are recorded.
No new treatments are given for this study; it observes existing care.
Information gathered helps improve future patient care.

Who may be eligible?

To be part of this study, you would need to be at least 18 years old. The study is specifically looking for people who have recently had a Type B aortic dissection, meaning it happened within the last 12 weeks. For the treatment to be possible, there needs to be a suitable area in your aorta where the repair can be performed. Also, the main abdominal part of your aorta shouldn't be wider than 42mm.

You would not be able to join if your Type B aortic dissection happened more than 12 weeks ago, or if you had a different type of aortic dissection. You also couldn't take part if you're already in another study involving a new device or medicine, or if you have a severe infection. If you've had certain other operations on your aorta recently, or have a severe allergy to materials used in the treatment, you also couldn't participate.

It's very important that you are able to understand what the study involves and are willing to give your permission to take part, as well as being able to attend all the necessary follow-up appointments.

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 18 years old or older?
Did you have a Type B aortic dissection in the last 12 weeks?
Are you able to agree to take part and attend follow-up appointments?
Have you had certain operations on your aorta recently?
Do you have severe allergies to materials like stainless steel or nitinol?

Answer every question to see your result.

What does participation involve?

This study primarily involves observing and recording information from patients who are receiving the STABILISE technique as part of their standard care for Type B aortic dissection. This is not a study where you would be given new, unapproved medication or a procedure developed solely for research. Instead, it's about carefully documenting the experiences and results of those who already qualify for and receive this specific treatment.

Taking part would mean that your medical details, including information about the procedure and your recovery, would be collected and recorded by the researchers. This helps them understand how well the STABILISE technique performs in real-world scenarios. The study will look at your results and anything that happens after the procedure. The exact number of visits or assessments isn't specified as this is a registry, meaning data is collected from your existing medical care. However, you would need to be available for any follow-up appointments that are part of your usual care, as the researchers would use this information.

Potential risks and benefits

There are no direct risks or benefits from simply participating in this registry, as it mainly involves collecting information from your existing medical care. The STABILISE technique itself, like any medical procedure, carries its own set of potential risks and benefits, which your doctor will fully discuss with you. The potential benefit of the study is that the information gathered will help doctors better understand this condition and treatment, potentially improving care for future patients. You are always free to withdraw your consent to have your data included in the study at any time, without affecting your medical treatment.

Locations (34)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Falk Cardiovascular Research Center
Verified postcode
Stanford, United States
Hartford Hospital
Verified postcode
Hartford, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
Cooper University Health Care
Verified postcode
Camden, United States
Columbia University Irving Medical Center
Verified postcode
New York, United States
Mayo Clinic
Verified postcode
Rochester, United States
UNC Hospitals
Verified postcode
Chapel Hill, United States
Providence Heart and Vascular Institute
Verified postcode
Portland, United States
Knight Cardiovascular Institute
Verified postcode
Portland, United States
Austin Hospital Heidelberg
Verified postcode
Victoria Park, Australia
St Vincent's Private Hospital Melbourne
Verified postcode
Melbourne, Australia
Herz Im Zentrum
Verified postcode
Neulengbach, Austria

Common questions

What is Type B aortic dissection?

It's a serious medical condition where there's a tear in the inner layer of the aorta, the body's main artery, specifically in a part called the descending aorta.

What is the STABILISE technique?

It's a special medical procedure used to treat aortic dissection, aiming to stabilise the torn aorta.

Is this study giving me an experimental treatment?

No, this study is observing and recording information from patients who are already receiving the STABILISE technique as part of their regular medical care.

How long will I be followed in the study?

The study will collect information based on your regular follow-up schedule with your doctors, which is part of your standard medical care.

What happens if I change my mind about being in the study?

You are free to withdraw your consent for your information to be used in the study at any time without it affecting your medical treatment.