Status:
UNKNOWN
Renal Stenting With Distal Atheroembolic Protection
Lead Sponsor:
Universita di Verona
Conditions:
Renal Artery Obstruction
Renovascular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function, refractory hypertension and flushing edema, responsible for mortality and morbidity, especially in t...
Detailed Description
This is a randomized trial of patients with an ostial ARAS and refractory hypertension and or renal failure. Patients will be randomized to: (i) renal artery stent placement with distal embolic prote...
Eligibility Criteria
Inclusion
- Age \>18 years
- Ostial atherosclerotic renal artery stenosis ≥70% on intra-arterial angiography
- Well documented history of hypertension (\>140/90 mmHg) non responsive to the use of 2 or more antihypertensive medications and/or
- Estimated glomerular filtration rate \<60 ml/min/1.73m2 according to the MDRD formula, on two occasions within one month
Exclusion
- Declined informed consent
- Renal longitudinal diameter \< 8 cm
- Any anatomical reasons that make impossible the PTRA and or the positioning of the distal embolic protection device
- Estimated glomerular filtration rate \<30 ml/min/1.73m2 according to the MDRD formula or on dialysis
- Allergy to the contrast medium used during angiography
- Other conditions associated with (within 6 months) poor prognosis
- Myocardial infarction, unstable angina or stroke \<1 month before planned date of inclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00868972
Start Date
March 1 2009
End Date
September 1 2011
Last Update
January 25 2010
Active Locations (1)
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1
Azienda Ospedaliera di Verona, Policlinico G.B. Rossi
Verona, Italy, 37134