1. The Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS) study: rationale and study design
- Author
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Rossi, Gp, Seccia, Tm, Miotto, D, Zucchetta, P, Cecchin, D, Calò, L, Puato, M, Motta, R, Caielli, P, Vincenzi, M, Ramondo, G, Taddei, Stefano, Ferri, C, Letizia, C, Borghi, C, Morganti, A, Pessina, Ac, Metras, Investigators, Cesari, M, Bui, F, Dessi, P, Taddei, S, Pinto, S, Belfiore, A., Rossi G.P., Seccia T.M., Miotto D., Zucchetta P., Cecchin D., Calò L., Puato M., Motta R., Caielli P., Vincenzi M., Ramondo G., Taddei S., Ferri C., Letizia C., Borghi C., Morganti A., and Pessina A.C.
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Renal function ,Kidney ,Renal Artery Obstruction ,Renal artery stenosis ,Revascularization ,Predictive Value of Tests ,Internal medicine ,medicine.artery ,Angioplasty ,Internal Medicine ,medicine ,Humans ,Prospective Studies ,Renal artery ,Antihypertensive Agents ,glomerular filtration rate ,business.industry ,angioplasty ,Kidney metabolism ,Ultrasonography, Doppler ,Atherosclerosis ,medicine.disease ,Stenosis ,Hypertension, Renovascular ,Treatment Outcome ,medicine.anatomical_structure ,Italy ,Cardiovascular Diseases ,Research Design ,Quality of Life ,Cardiology ,Technetium Tc 99m Pentetate ,Female ,Stents ,revascularization ,Radiopharmaceuticals ,Tomography, X-Ray Computed ,business ,Angioplasty, Balloon ,Biomarkers ,renal artery stenosi - Abstract
It is unclear whether revascularization of renal artery stenosis (RAS) by means of percutaneous renal angioplasty and stenting (PTRAS) is advantageous over optimal medical therapy. Hence, we designed a randomized clinical trial based on an optimized patient selection strategy and hard experimental endpoints. Primary objective of this study is to determine whether PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate (GFR) in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan. Secondary objectives of this study are to establish whether the two treatments are equivalent in lowering blood pressure, preserving overall renal function and regressing target organ damage, preventing cardiovascular events and improving quality of life. The study is designed as a prospective multicentre randomized, un-blinded two-arm study. Eligible patients will have clinical and angio-CT evidence of RAS. Inclusion criteria is RAS affecting the main renal artery or its major branches either >70% or, if
- Published
- 2012