Active not recruitingNAINTERVENTIONAL

SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study

This study, called SUCCESS, is observing a new medical device known as SELUTION SLR. This device is a special balloon, coated with medicine, designed to treat Peripheral Artery Disease (PAD). PAD happens when narrowed arteries reduce blood flow to your limbs, often your legs. This study aims to see how safe and effective the SELUTION SLR balloon is when used in actual patients as part of their standard care. Researchers will collect information on how patients respond to the treatment and how it impacts their overall health and quality of life over a period of five years. This type of study helps doctors understand more about new treatments after they've been approved for use.

At a glance

Status

Active not recruiting

Phase

Sponsor

M.A. Med Alliance S.A.

Enrolment target

723

Start

08 Feb 2021

Estimated completion

31 Dec 2028

Peripheral Artery Disease

What is this study about?

This study is called SUCCESS and it's looking at a new treatment for a condition called Peripheral Artery Disease, often shortened to PAD. PAD is a common condition where a build-up of fatty deposits in the arteries restricts blood supply to leg muscles, which can cause pain, especially during exercise.

The new treatment being studied is called SELUTION SLR. It's a special type of balloon that's used during a procedure to open up narrowed blood vessels. What makes this balloon different is that it's coated with a medicine that is released slowly into the blood vessel wall. The aim of this medicine is to help keep the artery open after the balloon has stretched it.

This study isn't testing whether the treatment works from scratch; rather, it’s keeping a close eye on how well the SELUTION SLR device performs and how safe it is in real-world situations, as it's already approved for use. Researchers will gather information from patients who receive this treatment as part of their regular care. They want to understand the long-term effects, including looking at patient health, understanding the costs involved compared to other treatments, and seeing how the treatment improves patients' daily lives over five years.

Key takeaways

This study evaluates a special balloon treatment for Peripheral Artery Disease (PAD).
It's observing the SELUTION SLR device, which is already an approved treatment.
The study aims to understand the treatment's safety and effectiveness over 5 years.
Information will be gathered on how the treatment impacts patients' health and quality of life.
Participation involves routine follow-up, not experimental drugs or procedures unique to the study.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. You must also be able to understand what the study involves and be willing to give your permission to participate. Importantly, your doctor must decide that the SELUTION SLR treatment is suitable for you, based on your specific health needs.

There are also a couple of reasons why you might not be able to join. If your doctor believes you have a serious illness that might mean you won't live for at least another year, then the study wouldn't be right for you. Also, if your doctor thinks you might have difficulty attending follow-up appointments over the five years, you wouldn't be able to take part.

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?
Can you understand and agree to take part in the study?
Has your doctor said the SELUTION SLR treatment is suitable for you?
Does your doctor believe you have a life expectancy of at least 12 months?
Are you likely to be able to attend follow-up appointments for five years?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the SELUTION SLR treatment for your Peripheral Artery Disease as part of your normal care. You won't be given any new or experimental medication to take. After your procedure, you'll be followed up by your medical team for five years. During this time, they will collect information about your health and how you are responding to the treatment. This will include answering questions about your general health and how your condition affects your daily life. If your usual care includes imaging scans (like ultrasounds), these results will also be collected. The total duration of your participation in the study from receiving the treatment will be five years.

Potential risks and benefits

Potential benefits of participating include receiving a treatment that your doctor believes is suitable for your Peripheral Artery Disease, and helping medical science learn more about how this device performs in the long term, which could help future patients. As with any medical procedure, there are potential risks, but these would be the same risks you'd face if you had the procedure outside of a study. Your medical team will explain all the potential side effects and complications of the procedure to you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (27)

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

Hospital Italiano La Plata
Verified postcode
La Plata, Argentina
Klinikum Hochsauerland
Verified postcode
Arnsberg, Germany
Universitätsklinikum Freiburg
Verified postcode
Bad Krozingen, Germany
Krankenhaus Buchholz
Verified postcode
Buchholz, Germany
Universitätsklinikum Essen
Verified postcode
Essen, Germany
DIAKO Krankenhaus
Verified postcode
Flensburg, Germany
Medizinisches Versorgungszentrum
Verified postcode
Hamburg, Germany
Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
SRH Klinikum Karlsbad - Langensteinbach
Verified postcode
Langensteinbach, Germany
LMU Klinikum Campus Großhadern
Verified postcode
München, Germany
Universitätsklinikum Tübingen
Verified postcode
Tübingen, Germany
Grn Klinik Weinheim
Verified postcode
Weinheim, Germany

Common questions

What is Peripheral Artery Disease (PAD)?

PAD is a condition where narrowed arteries reduce blood flow, most often to your legs, which can cause pain and other issues.

What is the SELUTION SLR balloon?

It's a special balloon coated with medicine, used to open up narrowed blood vessels in PAD. The medicine helps keep the artery open.

Is this a new treatment, or has it been used before?

This device is already approved for use, and this study is simply observing how it performs in real-world patients over time.

How long will I be involved in the study?

If you participate, your health will be monitored and data collected for five years after your procedure.

Will I have to take extra medication for the study?

No, you will not receive any additional medications for the purpose of this study. You will receive the standard of care as determined by your doctor.