Status:
UNKNOWN
Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS Study)
Lead Sponsor:
University Hospital Padova
Conditions:
Renal Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT). Since there are still uncertainties as to whether and in what patients revascularization by means of percutane...
Detailed Description
Background Renal atherosclerotic stenosis (RAS) is an increasingly prevalent causes of secondary hypertension (HT), and is becoming one of the first causes of end-stage renal failure requiring renal r...
Eligibility Criteria
Inclusion
- RAS affecting the main renal artery or its major branches at angio-CT either \> 70% or, if \< 70 with post-stenotic dilatation AND
- resistance index (RI) \< 0.55 or \> 0.55 but \< 0.80 with evidence of intrarenal heterogeneity of the RI as revealed by a CV \> 10% in the RI across the upper, mid and lower third of each kidney.
Exclusion
- refusal to participate to study,
- previous endovascular or surgical treatment of RAS,
- fibromuscular RAS,
- planned or actual pregnancy, or childbearing potential without measures adequate to prevent pregnancy,
- life expectancy \< 2 years,
- patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
- co-morbid conditions limiting participation and follow-up.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01208714
Start Date
December 1 2010
End Date
March 1 2016
Last Update
November 4 2010
Active Locations (1)
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1
Dept. Clinical and Experimental Medicine, University of Padova, Italy
Padua, Italy, 35128