RecruitingOBSERVATIONAL

PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

The PANTHER study is a registry designed to check the safety and performance of specific medical devices made by Terumo Aortic. These devices include knitted and woven grafts and cardiovascular patches. They are used to treat conditions like aneurysms (bulges in blood vessels) or dissections (tears in blood vessels) in areas such as the aorta and carotid arteries. The study collects information from patients both from the past and as new patients receive these devices, as part of their regular medical care. The main goal is to understand how these devices perform over time in real-world settings, helping doctors and manufacturers ensure they are safe and effective for people needing treatment for these serious heart and blood vessel conditions.

At a glance

Status

Recruiting

Sponsor

Vascutek Ltd.

Enrolment target

2,000

Start

17 Feb 2021

Estimated completion

01 Jan 2037

Aneurysm Dissection Aortic Root Aneurysm Aortic Root Dissection Carotid Artery Injuries Aortic Arch Bypass Extremity Graft Occlusive Vascular Disease Aortic Diseases

What is this study about?

The PANTHER Study is looking into how well certain medical devices work for patients who have problems with their blood vessels, especially the large ones like the aorta. These devices, called grafts and patches, are made by a company called Terumo Aortic. Think of a graft as a new section of blood vessel that replaces a damaged one, and a patch as a repair to a weak area.

Doctors use these grafts and patches to treat serious conditions like aneurysms, which are dangerous bulges in blood vessels, or dissections, which are tears in the vessel wall. They can occur in important areas like the aorta (the body's main artery) or the carotid arteries in the neck. The study wants to see how these devices perform outside of a strictly controlled trial setting, meaning in normal everyday medical practice.

This isn't a study where you get a new experimental treatment. Instead, it's a 'registry' study. This means it collects information about patients who are already receiving these specific Terumo Aortic grafts and patches as part of their standard care. By gathering this real-world information, the study aims to understand the safety and effectiveness of these devices over time. This helps doctors continue to provide the best care for patients with these kinds of blood vessel conditions.

Key takeaways

This study collects information on specific grafts and patches used for blood vessel problems.
It's a registry, meaning it observes regular patient care, not an experimental treatment.
Data is gathered from both past and current patients receiving these devices.
The goal is to understand how the devices perform safely and effectively in everyday use.
Participation helps improve future care for people with similar conditions.

Who may be eligible?

To be part of this study, you would generally need to be an adult (18 years or older, or the legal age in your area) and be receiving one of the specific Terumo Aortic grafts or patches as part of your standard medical treatment. You also need to be willing and able to follow your doctor's instructions for appointments and care related to your treatment.

For some patients, the study will look at your medical records from the past, meaning you might have had your surgery up to five years ago and have at least one year of follow-up information available. If you're a new patient receiving one of these devices, your information would be collected as you go along. It's important that you or your legal representative agree to share your medical information for the study.

However, you couldn't be in the study if you're unable to follow your usual medical care, if the device isn't suitable for you based on the manufacturer's guidelines, or if your doctor believes that taking part would not be right for your overall health.

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 to receive, or have you already received, a Terumo Aortic graft or patch for your condition?
Are you willing to let the study team look at your medical records?
Are you able to attend your regular doctor's appointments and follow-up care?

Answer every question to see your result.

What does participation involve?

Taking part in this study primarily involves allowing researchers to collect information about your medical care. If you are already a patient who has received one of the Terumo Aortic grafts or patches in the past, the study would mostly involve reviewing your existing medical records for information about your recovery and how the device performed. If you are a new patient receiving one of these devices, the study would collect information from your regular doctor's appointments and any follow-up care you have as part of your standard treatment. There are no extra tests or visits specifically for the study itself, beyond what your doctor would normally recommend for your condition. The overall duration for data collection can vary, as it involves reviewing past information or following new patients for a period as part of their ongoing care.

Potential risks and benefits

The main benefit of participating is that your health information will contribute to a better understanding of how these medical devices work in real patients, which can help improve treatments for others in the future. Since this study uses information from standard medical care and doesn't involve extra procedures, there are generally no additional physical risks beyond those already associated with your medical treatment. However, as with any study involving personal health information, there's a small risk to your privacy, though strict measures are in place to protect your data. You always have the right to withdraw your consent at any time, meaning you can stop your information from being used in the study.

Locations (31)

University of Colorado Anschutz
Verified postcode
Aurora, United States· Recruiting
University of South Florida - Tampa General
Verified postcode
Tampa, United States· Recruiting
Indiana University Health
Verified postcode
Indianapolis, United States· Recruiting
Duke University
Verified postcode
Durham, United States· Recruiting
East Carolina University
Verified postcode
Greenville, United States· Recruiting
University Hospitals Cleveland Medical Center
Verified postcode
Cleveland, United States· Recruiting
Ohio State University
Verified postcode
Columbus, United States· Recruiting
Lehigh Valley Hospital
Verified postcode
Allentown, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Virginia Commonwealth University
Verified postcode
Richmond, United States· Recruiting
UZ Gent
Verified postcode
Ghent, Belgium· Recruiting
AZ Groeninge Kortrijk
Verified postcode
Kortrijk, Belgium· Recruiting

Common questions

What exactly are 'grafts' and 'patches'?

Grafts are like new tubes that replace a damaged blood vessel, and patches are pieces of material used to repair or strengthen a weak spot in a blood vessel.

Will I get a different treatment if I join this study?

No, this study is about collecting information from standard medical care. You will receive the same treatment your doctor recommends, whether you join or not.

Do I need to take any new medication for this study?

No, there are no additional medications specifically for this study. You will continue with any medications prescribed by your doctor for your condition.

What does 'retrospective' patient mean?

A 'retrospective' patient is someone whose past medical records are being looked at for the study because they already had their treatment some time ago.

Is my personal information kept private?

Yes, all health information collected for the study is handled with strict confidentiality to protect your privacy.

How to find out more

Clinical Study Manager

r.smith1@terumoaortic.com +44 141 343 0194 Official trial record

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