Extrait

Background and study aims This study focuses on patients diagnosed with narrowing of the blood vessels that supply the heart muscle with blood. Patients will be treated with a procedure called Percutaneous Coronary Intervention (PCI), in which a small balloon will be inserted via an artery to the area of narrowing and then inflated. Once the blood vessel is enlarged, a small metal tube (a stent) will be placed into the blood vessel to keep it open and the balloon will be removed. The stent will remain in the blood vessel to hold it open so that the blood supply to the heart muscle will increase, which may improve symptoms such as angina. Several types of stents are available, usually either ‘bare metal’ or covered with a drug, called ‘drug eluting’. A bare metal stent may be susceptible to renarrowing of the surrounding blood vessel due to excess growth of natural tissue. Therefore, a newer type of stent has been developed which is coated with an antibody that attracts your own healing cells, which may improve healing and prevent excessive regrowth of natural tissue in the stent. This stent is called the Genous™ stent and has been approved for use for the treatment of narrowed coronary arteries. The aim of this study is to investigate the use of the Genous™ stent compared to the standard metal stent and to see whether the two stents produce similar clinical outcomes. Who can participate? Clinically stable patients undergoing a PCI for narrowed coronary arteries with a low risk of restenosis (recurrence) from various hospitals in Europe and elsewhere in the world. What does the study involve? Patients will be randomly allocated to be implanted with either the Genous™ or the bare metal stent. Patients will not be informed about which type of stent they will receive. The placement of either stent will be carried out by a interventional cardiologist according to the same standard procedure. After the stent has been implanted all participants will be approached for an evaluation over the telephone after one month, six months and one, two, three, four and five years. Patients will be questioned about any possible new heart complaints or other medical concerns that they have experienced. What are the possible benefits and risks of participating? Participation in the study is voluntary. If you do not participate in this study, the cardiologist will choose which stent to implant. Every participants is free to withdraw the consent for participation in the study at any time without care or treatment being affected. The study does not involve any extra costs and participants will not receive any financial compensation for taking part in this study. The usual clinical procedural risks of the implantation process will be explained before the procedure. There is no additional clinical risk associated with this study. This study will help tell us which of the stents best prevents narrowing and reduces long-term complications of this procedure. There are no known risks involved in the allocation of either type of stent. These stents are all approved for routine use. This will not have any effect on the rest of the medical treatment. Taking part in this study will not lead to any further tests. Where is the study run from? Academic Medical Centre (AMC) (Netherlands). When is the study starting and how long is it expected to run for? The study started in 2006 and is expected to end in 2019. Who is funding the study? Academic Medical Centre (AMC) (Netherlands) . Who is the main contact? Prof. Dr R.J. de Winter +31 20 566 9111

Critère d'inclusion

• Coronary artery lesions with a low risk of restenosis undergoing percutaneous coronary treatment

Liens

• ictrp
• isrctn