Status:
COMPLETED
Renal Atherosclerotic Revascularization Evaluation: RAVE Study
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Hypertension, Renovascular
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.
Detailed Description
It is uncertain whether patients with renal vascular disease will have renal or mortality benefits from re-establishing renal blood flow with renal revascularization procedures. Patients will be asses...
Eligibility Criteria
Inclusion
- Systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg despite at least 3 antihypertensive medications
- Systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg on two antihypertensives with: a rise in creatinine \> 20% after initiation of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB); the sudden onset of hypertension occurring after age 55; hypokalemia or the presence of an abdominal bruit; a history of flash pulmonary edema; or any three of: peripheral vascular disease, coronary artery disease, cerebrovascular disease, smoking, hyperlipidemia, diabetes or male gender.
Exclusion
- Serum creatinine \> 220 umol/L or estimated glomerular filtration rate (GFR) by Cockroft-Gault equation \< 20 ml/min
- Patients who are unwilling or unable to give informed consent
- Known contraindication to renal revascularization such as anaphylactic allergy to contrast dye
- An abdominal aortic aneurysm requiring surgery
- A single functioning kidney; a total occlusion of the renal artery or renal artery stenosis due to fibromuscular dysplasia.
- Previous revascularization
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00127738
Start Date
January 1 2005
End Date
December 1 2006
Last Update
January 11 2007
Active Locations (1)
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1
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5