RecruitingOBSERVATIONAL

Abbott Vascular Medical Device Registry

This study, called the Abbott Vascular Medical Device Registry, is collecting important information about how Abbott's medical devices, such as stents and other tools used in heart and blood vessel procedures, perform in everyday medical care. The main goal is to make sure these devices are safe and work well over time. Researchers are keeping an eye on how they're used and whether they continue to help patients as expected. This helps ensure that the benefits of using these devices outweigh any potential risks. Patients aged 18 and over who are having a procedure using one of these devices can take part if they agree and are able to attend follow-up appointments.

At a glance

Status

Recruiting

Sponsor

Abbott Medical Devices

Enrolment target

3,784

Start

25 Oct 2020

Estimated completion

01 Nov 2031

Acute Myocardial Infarction Restenoses, Coronary Coronary Artery Lesions Venous Embolism Arterial Embolism

What is this study about?

This study is called the Abbott Vascular Medical Device Registry, and its main purpose is to carefully watch how certain medical devices made by a company called Abbott are used in hospitals and clinics. These devices include things like stents, which are tiny tubes used to keep blood vessels open, and catheters, which are thin tubes used for various medical procedures. The study isn't testing new treatments; instead, it's about observing how devices that are already in use perform in the real world.

The study wants to collect information to confirm these devices are safe and effective over many years. This means looking at whether they work as they should, if there are any unexpected problems, and if they continue to provide good results for patients. By doing this, doctors and medical companies can be sure that these tools are still the best and safest options for treating conditions like heart attacks, blockages in blood vessels, and other related issues.

Basically, it's like a long-term check-up for medical devices. By gathering this real-life information, the study helps ensure that patients keep receiving the best possible care with devices that are proven to be safe and helpful. It also helps to prevent any misuse or unintended use of these devices, making sure they are always used in the safest and most effective way for each patient's condition.

Key takeaways

This study tracks how Abbott medical devices work in real patients.
It aims to confirm device safety and performance over time.
Participation involves allowing your medical information to be collected during your regular care.
You must be 18 or older and having a procedure with a specific Abbott device.
The study helps ensure future patients get safe and effective treatment.
You can stop participating at any time.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. You must also be having (or have recently had) a medical procedure where your doctor will use one or more of the specific Abbott medical devices that this study is tracking. This could include things like heart stents, or tools used for widening blood vessels or for accessing them.

Another important part of taking part is being willing and able to come back for any follow-up appointments needed to check on your health and how the device is working. Before you join, you'll need to sign a form that explains everything about the study, giving your permission for your health information to be collected.

However, you won't be able to join the study if you currently have symptoms, or have recently tested positive for, COVID-19 or another fast-spreading new infection within the last two months before your procedure. The study includes both men and women of all ages over 18.

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?
Are you having a procedure that will use an Abbott medical device (like a stent or catheter)?
Are you able to attend follow-up appointments as planned by your doctor?
Are you willing to sign a consent form to allow your medical details to be used for the study?
Have you not had COVID-19 or another new infection in the last two months?

Answer every question to see your result.

What does participation involve?

If you join this study, it means that information about your procedure involving an Abbott medical device, and how you recover afterwards, will be collected. This is a "registry" study, so there aren't any extra medications or treatments given as part of the study itself; you will just receive the standard care your doctor recommends. The study will track your progress over time through your regular follow-up appointments, as specified by the study plan. The total duration of your participation will depend on how long the researchers need to monitor the device's performance after your procedure, which will be explained to you in detail.

Potential risks and benefits

The main benefit of taking part in this study is contributing to important medical knowledge. The information gathered helps ensure that Abbott's medical devices remain safe and effective for future patients. There are no additional direct medical benefits or risks beyond those associated with your standard medical procedure and the device itself. You will not receive any experimental treatments. All participants have the right to withdraw from the study at any time without affecting their medical care.

Locations (37)

University Hospital - Univ. of Alabama at Birmingham (UAB)
Verified postcode
Birmingham, United States· Recruiting
Arkansas Heart Hospital
Verified postcode
Little Rock, United States· Recruiting
Kaiser Permanente Los Angeles Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Northwestern Memorial Hospital
Verified postcode
Chicago, United States· Recruiting
Bryan Heart
Verified postcode
Lincoln, United States· Recruiting
Ohio State University
Verified postcode
Columbus, United States· Recruiting
Wellmont CVA Heart Institute
Verified postcode
Kingsport, United States· Recruiting
Perth Institute of Vascular Research
Verified postcode
Nedlands, Australia· Recruiting
Sir Charles Gairdner Hospital
Verified postcode
Nedlands, Australia· Recruiting
Universitätsklinik Graz
Verified postcode
Graz, Austria· Recruiting
Onze-Lieve-Vrouwziekenhuis Campus Aalst
Verified postcode
Aalst, Belgium· Recruiting
AZ Sint-Blasius Ziekenhuis
Verified postcode
Dendermonde, Belgium· Recruiting

Common questions

What kind of devices are being studied?

The study is looking at devices like stents (which keep blood vessels open), catheters (thin tubes for various procedures), and other tools used in heart and blood vessel treatments.

Do I have to do anything extra if I join?

No, you just receive your usual medical care. The study mainly involves collecting information from your regular doctor's visits and procedures where an Abbott device is used.

Will I get special treatment if I join?

No, you will receive the same high standard of care you would normally get. The study is about observing standard practice, not changing it.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care or relationship with your doctors.

What happens to my personal information?

Your personal data will be kept confidential and used only for research purposes, following strict privacy rules. Your name won't be shared in study reports.

How to find out more

Sharan Dhanjal, MPH

sharanjeet.dhanjal@abbott.com +1 714-926-8292 Official trial record

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