RecruitingNAINTERVENTIONAL

A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta

This study is evaluating a new medical device called Rapidlink. Surgeons use this device during open heart surgery to repair or replace important blood vessels that branch off the main artery in your chest, called the aorta. The aim is to see how safe and effective Rapidlink is for people undergoing surgery for conditions such as an aortic aneurysm in the chest. It's hoped that Rapidlink will make this part of the surgery simpler and quicker for surgeons, especially when dealing with tricky blood vessels or those affected by disease.

At a glance

Status

Recruiting

Phase

Sponsor

Vascutek Ltd.

Enrolment target

150

Start

19 Dec 2025

Estimated completion

01 Nov 2028

Aortic Aneurysm Aortic Aneurysm and Dissection Aortic Diseases Aneurysm of Aorta, Thoracic Aneurysmal Disease Aorta, Thoracic Pathologies

What is this study about?

This study is looking at a new device called Rapidlink, which surgeons use when operating on the main artery in your body, called the aorta. The aorta runs from your heart and carries blood to the rest of your body. Sometimes, parts of the aorta in your chest can become weak and bulge, which is called an aneurysm, or develop other issues. When this happens, surgery might be needed to repair it.

During open surgery to fix problems with the aorta in the chest, surgeons sometimes need to repair or replace some smaller but very important blood vessels that branch off the aorta and supply blood to your head and arms. This part of the operation can sometimes be quite delicate and challenging. The Rapidlink device is designed to make it easier and quicker for surgeons to connect these critical blood vessels back to the main repair, using a special type of stent.

The main goal of this study is to check how safe and effective the Rapidlink device is. Researchers will collect information from patients who are already having this type of aortic surgery and are having the Rapidlink device used. They want to see if it helps with the surgery and how patients recover afterwards. This is important because it could lead to better surgical outcomes for people needing these complex repairs.

Key takeaways

Researches are studying a new device called Rapidlink for aortic surgery.
The study focuses on its safety and effectiveness during open chest aorta repair.
It aims to simplify repairs of vital blood vessels branching off the aorta.
Participants are already scheduled for this type of major surgery.
Follow-up checks will occur for up to two years post-surgery.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. You must also be scheduled for open heart surgery to repair a problem with your aorta in the chest, and your surgeon must plan to use the Rapidlink device to fix certain blood vessels that branch off your aorta.

There are also some specific measurements and conditions related to your blood vessels that would need to be suitable for the device. For example, your blood vessels should be within a certain size range and not have severe blockages, narrowing, or unusual twists that would prevent the device from working properly.

You would not be able to join the study if you have certain conditions, such as a severe allergy to the materials the device is made of, uncontrolled blood clotting issues, an infection in your aorta, or if you couldn't have important follow-up scans. Also, if your surgeon believes you are not well enough for this kind of major surgery, you wouldn't be able to participate.

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 scheduled for open surgery to repair a problem with your aorta in the chest?
Does your surgeon plan to use the Rapidlink device during your surgery?
Do you not have an active infection or severe allergic reactions to materials like polyester or nitinol?
Are your blood vessels suitable in size and condition for the device?

Answer every question to see your result.

What does participation involve?

If you are part of this study, you would be having open surgery to repair your aorta as planned. During this surgery, the Rapidlink device would be used to repair or replace specific blood vessels branching off your aorta. After your surgery, the research team will collect information about your recovery during your hospital stay and at set times after you leave. This will involve follow-up appointments or checks at 30 days, 6 months, 1 year, and 2 years after your operation. These visits will likely include examinations and possibly scans to see how you are doing and how the device is working.

Potential risks and benefits

Taking part in this study means you'd be receiving a new device during your planned surgery. The potential benefits could include a potentially simpler and quicker part of your surgery involving the tricky blood vessels coming off your aorta, which might contribute to a smoother surgical process. However, as with any medical procedure or new device, there are potential risks, including those associated with major surgery itself and those specific to the Rapidlink device, which the medical team would discuss fully with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (23)

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

Keck Medicine of USC
Verified postcode
Los Angeles, United States· Not yet recruiting
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Not yet recruiting
University of Colorado Anschutz Medical Campus
Verified postcode
Aurora, United States· Not yet recruiting
Medstar Washington Hospital Center
Verified postcode
Washington D.C., United States· Not yet recruiting
UF Health Shands Hospital
Verified postcode
Gainesville, United States· Not yet recruiting
Baptist Hospital of Miami
Verified postcode
Miami, United States· Not yet recruiting
Tampa General Hospital
Verified postcode
Tampa, United States· Not yet recruiting
Northwestern Memorial Hospital
Verified postcode
Chicago, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Not yet recruiting
Mayo Clinic Rochester
Verified postcode
Rochester, United States· Not yet recruiting
Barnes-Jewish Hospital
Verified postcode
St Louis, United States· Recruiting
Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States· Not yet recruiting

Common questions

What is an aortic aneurysm?

An aortic aneurysm is a bulge or weak spot in the wall of your aorta, the main blood vessel leaving your heart. If it gets too big, it can be dangerous.

What does 'open surgical repair' mean?

Open surgical repair means surgeons make an incision to operate directly on the affected part of your aorta, rather than using smaller cuts as in keyhole surgery.

What is the Rapidlink device?

The Rapidlink is a new device designed to help surgeons during open aortic surgery. It simplifies the process of connecting important branch blood vessels to the repaired aorta.

Will I get this device if I join the study?

Yes, if you meet the study criteria and are enrolled, the Rapidlink device will be used during your planned open surgery to repair your aorta.

What happens after the surgery?

After surgery, the study team will monitor your recovery with follow-up appointments over two years to see how you and the device are doing.

How to find out more

Sarah Macluskie

s.macluskie@terumoaortic.com +441413430333 Official trial record

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