PATIENT CONTENT – PRE-CE MARK/CLINICAL TRIAL STAGE
You are seeing this webpage because you are participating in a research study (a “clinical study”) evaluating the Allay® Aortic Stent for its potential in treating aortic dissection. The information included here is extracted from the document you received prior to agreeing to participate in this clinical study.
What is the Allay® Aortic Stent?
The Allay® Aortic Stent is an implantable medical device; it has not yet received the necessary authorization to be put on the market in any country. It is manufactured according to the highest quality standards applicable for cardiovascular implants.
The Allay® Aortic Stent is a metallic stent with unique properties, allowing it to reopen the compressed right channel for blood, whilst, thanks to its permeable structure, preserving blood flow to the organs and tissues.
The Allay® Aortic Stent implant is composed of a cobalt alloy metal combination and is designed as a radiopaque tubular self-expandable stent implant.
The device does not contain any medicinal substances.
The Allay® Aortic Stent
Has this medical device been used in people?
A previous version of the Allay® Aortic Stent has already been brought to the market to treat another disease in 2011 and been used since in clinical studies of patients with Type B aortic dissection in Europe, including in a study involving 20 patients already followed for approximately 5 years. New clinical studies are now being run to collect additional information on how well this device works and on the side effects it has.
How is the device implanted?
The Allay® Aortic Stent implant is being implanted in your aorta by a qualified physician. To do this, the physician will proceed with a technique called endovascular, a minimally invasive technique where the physician uses tiny incision in your groin to access your vessels and deploy the stent in the affected zone. One or 2 implants may be used to cover the dissected aorta.
Your participation to a clinical study is voluntary. You may choose not to be in the study, and you may withdraw from the study at any time. There will be no penalty or loss of benefits to you, and you will continue to receive regular medical care as per the standard of care.
If you have any questions about being part of this study, if you feel you have suffered an injury or have been hospitalized because of the study, or if you have any concerns or complaints about the study, please contact your study doctor.
Contact
For more information on Intressa Vascular or the Allay Aortic Stent, please provide your contact information.
