Clinical Trial Overview

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.

During the procedure, a balloon catheter will be placed in the renal artery where the disease has been diagnosed. The doctor performing the procedure will decide whether the balloon alone (without a stent placed) provides adequate blood flow in the renal arteries. If the balloon catheter alone does not provide adequate blood flow, a stent will be placed where the angioplasty was attempted.

After placement of the stent, you will be asked to make periodic clinic visits. You will also be contacted by phone several times over a three-year period. Nine months after the stent is implanted, you will be asked to have a non-invasive ultrasound evaluation to see that your renal artery is adequately open with good blood flow to the kidney. You will be carefully monitored by clinical assessments over the three-year period for blood pressure, antihypertensive medications and any other items related to the trial.