Guidelines for the Reporting of Renal Artery Revascularization in Clinical Trials

Abstract

A lthough the treatment of atherosclerotic renal artery stenosis with percutaneous angioplasty, stenting, and surgical revascularization has gained widespread use, few prospective randomized controlled trials (RCTs) exist that compare these techniques with each other or against the standard of medical management alone. To facilitate this process and help answer many important questions about the appropriate application of renal revascularization, welldesigned 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, the present statement provides guidelines and definitions for the design, conduct, evaluation, and reporting of renal artery revascularization RCTs. In addition, areas of critically needed renal artery revascularization investigation are identified. It is hoped that this information will be valuable to the investigator who wishes to conduct research in this important area.