Heart Association Councils on Cardiovascular Radiology, High Blood Pressure Research, Kidney in Cardiovascular Disease, and Clinical Cardiology, and the Society of Interventional Radiology FDA Device Forum Committee

Although the treatment of atherosclerotic renal artery stenosis with use of percutaneous angioplasty, stent placement, and surgical revascularization has gained widespread use, there exist few prospective randomized controlled trials (RCTs) comparing these techniques to each other or against the standard of medical management alone. To facilitate this process as well as help answer many important questions regarding the appropriate application of renal revascularization, well-designed and rigorously conducted trials are needed. These trials must have clearly defined goals and must be sufficiently sized and performed so as to withstand intensive outcomes assessment. Toward this end, this document provides guidelines and definitions for the design, conduct, evaluation, and reporting of renal artery revascularization RCTs. In addition, areas of critically necessary renal artery revascularization investigation are identified. It is hoped that this information will be valuable to the investigator wishing to conduct research in this important area. J Vasc Interv Radiol 2003; 14:S477–S492 Abbreviations: GFR glomerular filtration rate, PTRA percutaneous transluminal renal angioplasty, RAS renal artery stenosis, RCT randomized con-trolled trial I. OVERVIEW The use of revascularization tech