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Completed

NCT Number: NCT00127738

Renal Atherosclerotic Revascularization Evaluation: RAVE Study

The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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 assessed for the standard nephrology research outcomes of progression to doubling of creatinine, need for dialysis, and death, as well as other cardiovascular outcomes. The investigators will also establish whether the use of a new inexpensive, simple and available ultrasound test, the renal resistance index (RRI), can identify patients with renal vascular disease who will not benefit from renal revascularization procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Angiographic renal revascularization

Procedure

Primary outcomes

  1. Dialysis

  2. Death

  3. Doubling of creatinine

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Aug 8, 2005
Registry last updated
Jan 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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