Guidelines for the reporting of renal artery revascularization in clinical trials.
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.
Rundback
John H
JH
Columbia Presbyterian Medical Center, Milstein Pavilion, Vascular and Interventional Radiology, New York, NY 10032, USA. rundback@msn.com
Sacks
David
D
Kent
K Craig
KC
Cooper
Christopher
C
Jones
Daniel
D
Murphy
Timothy
T
Rosenfield
Kenneth
K
White
Christopher
C
Bettmann
Michael
M
Cortell
Stanley
S
Puschett
Jules
J
Clair
Daniel G
DG
Cole
Patricia
P
D000800:Angioplasty, Balloon; D006801:Humans; D008499:Medical Records / Q000592:standards; D015337:Multicenter Studies as Topic / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012077:Renal Artery / Q000601:surgery; D012078:Renal Artery Obstruction / Q000175:diagnosis / Q000601:surgery / Q000628:therapy*; D015607:Stents