Active not recruitingNAINTERVENTIONAL

Clinical Trial Investigating the BeGraft Peripheral Plus Stent Graft System for Iliac Lesion Treatment

This study is investigating a medical device called the BeGraft Peripheral Plus Stent Graft System. It's designed for people with Peripheral Arterial Disease (PAD), a condition where arteries in the legs narrow or block, reducing blood flow. The study will assess how well this special tube (stent) improves blood flow in the iliac arteries (major arteries in the pelvis) and keeps them open over time. Researchers also want to confirm its safety. Patients in the study will have follow-up visits for up to three years to check their progress. The goal is to see if this stent is a good long-term solution for improving circulation in people with PAD.

At a glance

Status

Active not recruiting

Phase

Sponsor

ID3 Medical

Enrolment target

Start

29 Nov 2017

Estimated completion

01 Apr 2025

Peripheral Arterial Disease

What is this study about?

This study is all about a new medical device called the BeGraft Peripheral Plus Stent Graft System. This system is like a tiny, mesh tube that doctors place inside narrowed or blocked blood vessels to help keep them open. The study focuses on people who have a condition called Peripheral Arterial Disease (PAD), specifically when it affects the iliac arteries in the pelvis and upper legs. These arteries can become narrowed or blocked, making it hard for blood to flow properly.

The main aim of this research is to see how well this special stent works to improve blood flow and if it stays open over a long period. They also want to make sure it's safe for patients. Doctors will place the stent inside the affected artery, and then patients will be carefully monitored for up to three years to see how they are doing. This study will help doctors understand if the BeGraft Peripheral Plus Stent Graft System is a good and lasting treatment for people with PAD affecting these important arteries.

By carefully studying how this device performs in a group of patients, doctors can learn more about its benefits and any potential drawbacks. This information is really important for making sure that patients who need this kind of treatment get the best possible care and that new technologies are both effective and safe for widespread use.

Key takeaways

This study evaluates a new stent (BeGraft Peripheral Plus) for blocked leg arteries (PAD).
It aims to see how well the stent improves blood flow long-term and its safety.
Patients will have check-ups for up to 3 years after the procedure.
The research focuses on important arteries in the pelvis and upper legs.
It's for adults over 18 with specific narrowing or blockages suitable for a stent.

Who may be eligible?

To join this study, you generally need to be an adult over 18 years old. You would have Peripheral Arterial Disease where some of your main leg arteries (called iliac arteries) are narrowed or blocked. Doctors would need to confirm that placing a stent is a suitable treatment option for you.

Your overall health should be stable, meaning you don't have other serious medical conditions that would make it difficult for you to take part or attend your follow-up appointments. You also need to be able and willing to cooperate with the study's requirements and attend all planned check-ups for up to three years. Your local healthcare team will help check if you meet all the specific criteria.

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 over 18 years old?
Do you have Peripheral Arterial Disease affecting your main leg arteries?
Has your doctor said that a stent might be a good option for your condition?
Are you able and willing to attend follow-up appointments for up to 3 years?
Is your overall health stable enough to participate in a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have some standard medical checks, like reviewing your health history and current medications. Before your procedure, you'll have specific scans and measurements taken to assess your blood vessels.

During the procedure, doctors will place the BeGraft Peripheral Plus Stent Graft System in your narrowed or blocked artery. You might need some pre- or post-procedure balloon treatment, depending on what your doctor thinks is best for your specific case. After the procedure, you'll have several follow-up visits over three years. These visits will be at 1, 6, 12, 24, and 36 months after your procedure. During these check-ups, doctors will monitor how well the stent is working and check your general health.

Potential risks and benefits

Taking part in this study means you might benefit from a new device designed to improve blood flow in your legs, potentially easing symptoms of Peripheral Arterial Disease. However, as with any medical procedure, there are potential risks, such as difficulties during the stent placement, or issues with the stent later on. The study is carefully designed to monitor these risks closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

O.L.V. Hospital
Verified postcode
Aalst, Belgium
ZNA
Verified postcode
Antwerp, Belgium
Imelda Hospital
Verified postcode
Bonheiden, Belgium
A.Z. Sint-Blasius
Verified postcode
Dendermonde, Belgium
ZOL
Verified postcode
Genk, Belgium
az Groeninge
Verified postcode
Kortrijk, Belgium
RZ Heilig Hart
Verified postcode
Tienen, Belgium
AZ Jan Portaels
Verified postcode
Vilvoorde, Belgium
CHU de Nantes
Verified postcode
Nantes, France

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a common condition where narrowed arteries reduce blood flow to your limbs, most commonly your legs, which can cause pain when walking.

What is a 'stent graft system'?

It's a small, mesh tube that doctors place inside a narrowed or blocked artery to help keep it open and allow blood to flow freely.

How long will I be in this study?

If you join, you'll have follow-up appointments for up to three years after the procedure to check your progress.

Will I have different treatment if I join this study?

The study uses a specific type of stent. Other treatments might be available, but this study focuses on how well this particular device works for your condition.

Can I leave the study if I change my mind?

Yes, you can decide to leave the study at any point, and it won't affect the care you receive for your condition.