The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
This study investigates a new medical device called the GORE VIABAHN FORTEGRA Venous Stent. It's designed to treat problems with large veins in your body, particularly those in your tummy (abdomen) and legs. These problems can lead to uncomfortable symptoms like leg swelling, pain, and skin sores (ulcers) if the veins are blocked or narrowed. This study aims to see how well the new stent works, how safe it is, and if it helps to improve patients' symptoms. Researchers will be following over a hundred patients who receive this stent to understand its performance over several years.
At a glance
What is this study about?
Imagine your veins as roads that carry blood back to your heart. Sometimes, these roads can get blocked or narrowed, especially in your legs or a main vein in your tummy called the inferior vena cava. This can cause various issues, including swollen legs, pain, or even persistent leg ulcers that are hard to heal. These symptoms can really impact your daily life and comfort.
This study is looking at a new type of tube, called a stent, named the GORE VIABAHN FORTEGRA Venous Stent. This stent is designed to open up these blocked or narrowed veins, helping blood to flow more freely. The main goal of this study is to see if this new stent can effectively improve these symptoms and help people feel better.
Doctors taking part in this study will carefully monitor patients who receive this stent. They want to check how safely and effectively the stent works over a long period, making sure it stays open and helps to relieve the vein problems.
Key takeaways
- This study explores a new stent to treat severe vein problems in the legs and tummy.
- It aims to reduce symptoms like swelling, pain, and leg ulcers.
- Participation involves receiving the stent and attending regular check-ups for up to five years.
- The study assesses how well and how safely the stent works long-term.
- It's for adults over 18 with specific, problematic vein blockages.
Who may be eligible?
To join this study, you need to be at least 18 years old and able to attend all the follow-up appointments. You should also be able to understand the study and agree to take part. Generally, you would be considered if you have noticeable symptoms from vein problems, such as ongoing leg swelling, pain, or skin sores that don't heal easily, caused by a blockage in a major vein.
You wouldn't be able to join if you are pregnant, breastfeeding, or planning to get pregnant soon. You also couldn't take part if you have certain medical conditions like severe kidney problems, unmanaged bleeding issues, or recent untreated blood clots in your lungs. The doctors also need to make sure you're healthy enough to have the procedure and that you're expected to live for at least another year.
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 at least 18 years old?
- Do you have ongoing symptoms like leg swelling, pain, or unhealing leg sores from vein trouble?
- Are you able to attend several follow-up appointments over five years?
- Are you not pregnant or breastfeeding, and not planning pregnancy in the next year?
- Do you have a general good health outlook for at least the next year?
- Are you able to walk, even if you need a walking aid?
What does participation involve?
If you decide to take part, you would receive the GORE VIABAHN FORTEGRA Venous Stent to help with your vein condition. After the procedure, the study team will ask you to visit the hospital or clinic for check-ups. These visits will happen at one month, six months, one year, two years, three years, four years, and five years after your stent is placed. During these visits, doctors will check how you're feeling, how the stent is working, and if your symptoms have improved. You will also need to follow any medication or compression (like special stockings) advice given by your doctor.
Potential risks and benefits
Locations (17)
- Stanford University School of MedicineVerified postcodeStanford, United States
- MedStar Washington Hospital CenterVerified postcodeWashington D.C., United States
- NorthwesternVerified postcodeChicago, United States
- University of MichiganVerified postcodeAnn Arbor, United States
- Mount Sinai Medical CenterVerified postcodeNew York, United States
- Weill Cornell Medical CollegeVerified postcodeNew York, United States
- Atrium Health-Sanger Heart and Vascular InstituteVerified postcodeCharlotte, United States
- SentaraVerified postcodeNorfolk, United States
- Flinders Medical CentreVerified postcodeAdelaide, Australia
- Universitätsklinikum AachenVerified postcodeAachen, Germany
- Alexianer Klinikum Hochsauerland GmbHVerified postcodeArnsberg, Germany
- University College Hospital GALWAY /Clinical Research Facility GalwayVerified postcodeGalway, Ireland
Common questions
What is a stent?
A stent is a small, mesh tube that doctors can put into a vein to help keep it open, especially if it's blocked or narrowed, allowing blood to flow more freely.
What kind of vein problems is this study looking at?
This study is focused on issues with major veins, especially in your tummy and legs, that cause symptoms like swelling, pain, or leg ulcers.
How long will I be followed in the study?
If you join, you'll have follow-up visits for up to five years after receiving the stent.
Will I get normal medical care if I don't join this study?
Yes, your decision about the study won't affect the medical care you normally receive.
Is this a new type of stent?
Yes, this study is evaluating a new version of a venous stent designed to treat these specific vein problems.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.