Clinical Trial: Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)

Brief Summary: This study will compare medical therapy plus stenting of hemodynamically significant renal artery stenoses versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.

Detailed Summary:

BACKGROUND:

Atherosclerotic renal artery stenosis is a common problem for which there is no clear consensus on diagnosis or therapy. There likely exists a progression in which renal ischemia leads to neuroendocrine activation, hypertension, and renal insufficiency resulting in acceleration of atherosclerosis, further renal dysfunction, and development of left ventricular hypertrophy. These events in turn lead to adverse clinical events.

Renal artery stenosis is one of the two major known causes of hypertension and occurs in 1-5% of hypertensive patients. In patients with accelerated hypertension, the prevalence of renal artery stenosis is much higher, ranging from 10-40%. Renal artery stenosis, when occurring bilaterally, or in a solitary kidney, is a significant cause for end-stage renal disease, accounting for several percent of patients with end-stage renal disease. Clinically, atherosclerotic renal artery stenosis is a major problem primarily in older patients, and is often seen in long-standing hypertensives whose blood pressure becomes very difficult to control. Of major significance is the progressive nature of atherosclerotic renal artery stenosis, progressing at the rate of about 10% per year (45-60% progression rate in 4-7 year follow-ups). Over this time period, 10-15% of patients develop total renal artery occlusion. If the renal artery stenosis is greater than 75% when detected, 40% of patients develop total occlusion. Due to the progressive nature of atherosclerotic lesions, the decline in renal function in some individuals, and difficult-to-control hypertension, the medical community has sought to detect those patients in whom intervention would be beneficial. This has been extremely difficult to achieve and tests to date have not been uniformly predictive, including peripheral vein plasma renin activity, re
Sponsor: Baim Institute for Clinical Research

Current Primary Outcome:

  • Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]
    Only the first event per participant is included in the composite
  • Cardiovascular or Renal Death [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]
  • Myocardial Infarction [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]
  • Hospitalization for Congestive Heart Failure [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]
  • Stroke [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]
  • 30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]
  • Need for Renal Replacement Therapy [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Baim Institute for Clinical Research

Dates:
Date Received: April 19, 2004
Date Started: April 2004
Date Completion:
Last Updated: September 18, 2015
Last Verified: September 2015