|Age:||18+ years old|
|Keywords:||coronary artery disease, coronary stent|
In order to meet requirements for participation in this study, you must receive at least one XIENCE stent. Your study doctor will confirm you qualify for this study. Information on your medical history and any blood thinning (antiplatelet) medications will also be collected.
Angiogram/Coronary Stenting Procedure
BEFORE PROCEDURE: Potential Study subjects may receive the following standard of care tests and procedures:
DURING PROCEDURE: Your Study Doctor will perform an angiogram (special x-ray of your coronary artery). It will be done at the beginning of your procedure to determine where the narrowing is and how much narrowing you have.
The stent procedure is routine. Your Study Doctor will tell you what he or she will do before, during and after placement of your stent.
First, your Study Doctor may use a special x-ray (angiogram) to move a long, thin, hollow tube (catheter) with a deflated balloon mounted on its tip through your heart artery and into the narrowed area (lesion). Your Study Doctor will temporarily inflate the balloon to push open the narrowed part of the artery, pushing the blockage against the artery wall. This stretches the narrowed artery open so blood can flow more easily to the heart. Then the balloon is deflated and taken out of the artery. Second, your Study Doctor will implant a XIENCE stent into your heart artery. The device is placed over a balloon catheter and delivered to the narrowed part of the heart artery. When the balloon is inflated, the device expands and is pressed against the wall of the heart artery. Once the stent is properly placed, the balloon will be removed from your body. The delivery catheter is then removed, leaving the stent in your artery. Finally, your Study Doctor may move another catheter with a deflated balloon through the stented area of your heart artery and temporarily inflate the balloon to expand the stent further. This balloon will then be deflated and taken out of the artery. The first and last steps of balloon inflation prior to and after stent implant are optional for this kind of stent procedure and will be decided by your Study Doctor.
AFTER PROCEDURE: Before you are released from the hospital, you may receive the following standard of care tests:
After hospital discharge you will be asked to return up to 3 times for follow-up visits. The first follow-up will take place at approximately 90 days (3 months). The other two visits can be conducted via in office visit or telephone at 180 days (6 months), and 365 days (1 year).