RecruitingOBSERVATIONAL

Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature

This study, called ELEGANCE, is collecting information on how well certain drug-coated devices from Boston Scientific work when used in real-life medical practice. These devices are used to treat problems in the blood vessels outside of the heart and brain, a condition often called Peripheral Vascular Disease (PVD). The study aims to get a better understanding of how these devices help a wide range of patients, including those who might not have been included in previous research. It also looks at the economic impact of these treatments and supports their safe use, helping to improve care for people with PVD.

At a glance

Status

Recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

5,000

Start

29 Mar 2021

Estimated completion

01 Jan 2028

Peripheral Vascular Diseases

What is this study about?

This study, called the ELEGANCE Registry, is like a large observation project. It's designed to gather a lot of information about how a special type of medical device works in real patients. These devices are made by Boston Scientific and have a special coating that releases medication directly into the blood vessels. They are used to treat a condition called Peripheral Vascular Disease (PVD), which affects the blood vessels in parts of the body like the legs and arms.

The main goal is to understand how these drug-coated devices perform in everyday medical practice, not just in highly controlled research settings. This is important because it allows doctors to see how well they work for a wider variety of patients, including those who might have other health conditions that made them unsuitable for earlier studies. The study also looks at the costs involved with these treatments and generally aims to support their safe use, ensuring patients get the best possible care.

By collecting this 'real-world data', researchers hope to get a clearer picture of the benefits and challenges of using these devices. This information can then help doctors make better decisions about treatment for people with PVD, leading to improved health outcomes and a better understanding of how healthcare resources are used.

Key takeaways

This study collects real-world information on established treatments for blood vessel problems.
It helps doctors understand how drug-coated devices work for many different patients.
Participation involves sharing your routine medical data, not undergoing new treatments.
The information gathered could help improve future care for people with Peripheral Vascular Disease.
Your privacy is protected, and you can withdraw from the data collection at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You also need to be able to understand and sign a consent form, which allows the researchers to use your health information for the study.

Specifically, you must be someone who is receiving treatment for blood vessel problems in your arms or legs using a special drug-coated device made by Boston Scientific. The device must be one that is approved for use and listed in the study's guide.

There's only one main reason you wouldn't be able to join: if your doctors believe you have less than one year to live. Otherwise, if you meet the other criteria and are being treated with one of the specified devices, you might be eligible.

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 receiving treatment for blood vessel problems in your limbs with a Boston Scientific drug-coated device?
Are you able to provide written consent for your information to be used?
Do you expect to live for more than one year?

Answer every question to see your result.

What does participation involve?

If you take part in this registry, it largely involves allowing your doctors to share information about your treatment with the study researchers. You won't be given any new or experimental medications. Instead, the study will track what happens when you receive one of the commercially available Boston Scientific drug-coated devices as part of your standard medical care for blood vessel problems. This means you'll have your usual doctor's appointments and treatments, and the study will simply collect data from those visits. There are no additional study visits or extra procedures specifically for the research. The duration of your participation will depend on how long your doctor follows your condition, as the study collects ongoing real-world information.

Potential risks and benefits

Since this is a registry observing standard care rather than testing a new treatment, there are no additional medical risks beyond those usually associated with receiving the Boston Scientific drug-coated device for your condition. The main 'risk' is related to your privacy, as your health information will be collected, but strict measures are in place to keep your data confidential. The potential benefit isn't a direct improvement in your health from participating, but rather contributing valuable information. Your involvement helps doctors and researchers understand how these devices work in real-world situations for many different patients, which can improve treatments for others in the future. You always have the right to withdraw your consent for your data to be collected at any time, without it affecting your medical care.

Locations (79)

St. Bernard's Medical Center
Verified postcode
Jonesboro, United States· Recruiting
PIH Health Good Samaritan Hospital
Verified postcode
Los Angeles, United States· Recruiting
Cedars - Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Ronald Reagan UCLA Medical Center
Verified postcode
Los Angeles, United States· Withdrawn
Sutter Medical Center, Sacramento
Verified postcode
Sacramento, United States· Completed
Adventist Health St Helena Hospital
Verified postcode
St. Helena, United States· Recruiting
Yale University School of Medicine
Verified postcode
New Haven, United States· Recruiting
Christiana Hospital
Verified postcode
Newport, United States· Recruiting
Washington Hospital Center
Verified postcode
Washington D.C., United States· Recruiting
Palm Beach Heart & Vascular, LLC
Verified postcode
Boynton Beach, United States· Withdrawn
Tallahassee Memorial Hospital
Verified postcode
Tallahassee, United States· Recruiting
Emory University Hospital
Verified postcode
Atlanta, United States· Recruiting

Common questions

What is Peripheral Vascular Disease (PVD)?

PVD is a condition where narrowed blood vessels reduce blood flow to your limbs, often your legs. It can cause pain, cramping, and other problems.

What is a drug-coated device?

It's a medical device, like a stent or a balloon, that has a special coating that slowly releases medication to help keep your blood vessels open and prevent them from narrowing again.

Will I receive new medicine as part of this study?

No, you won't receive new or experimental medicine. This study observes how devices already on the market are used in regular medical care.

Will this study change my medical treatment?

No, your medical treatment will be decided by your doctor as usual. This study just collects information about the treatment you are already receiving.

How will my personal information be protected?

The study will take great care to protect your privacy and keep your health information confidential. Only necessary details will be used for research.

How to find out more

Yumna Akhtar, MS

yumna.akhtar@bsci.com 651-399-6775 Official trial record

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