Is the Formula 418 Balloon Expandable Stent Trial right for me?
Only you and your doctor can determine the best treatment for your renal artery disease. This site provides details about the clinical trial and will help you to speak with your doctor about which treatment is best for you.
The purpose of this clinical trial is to evaluate the safety and effectiveness of Cook Medical’s Formula 418 Balloon Expandable Stent in the treatment of renal artery atherosclerosis.
According to clinical studies*, balloon angioplasty alone can sometimes open renal arteries sufficiently to restore adequate blood flow. Stents have proven useful in holding open those renal arteries that did not remain open after angioplasty. One of our goals with this study is to compare the results of stent implantation with the results previously reported* for balloon angioplasty of the renal arteries. We are seeking FDA approval of the use of this stent in the renal arteries. This study will also investigate changes in your blood pressure and renal function. Read more...
What is Renal Artery Disease?
Renal artery disease is a narrowing of the blood vessels that lead to the kidneys. Plaque (fatty deposits and calcium) can collect within these arteries, reducing the diameter of the blood vessel and thereby reducing blood flow to the kidneys. The kidneys may then send signals for more blood, and the body increases its blood pressure in response. This high blood pressure, coupled with the atherosclerosis, greatly increases stress on the heart and could also lead to a stroke. Read more...
