CompletedPhase 3

Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions

United States947 participantsStarted 2004-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Either
✓. Documented history of hypertension on two or more anti-hypertensive medications OR
✓. Renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate \[GFR\] less than 60 mL per minute per 1.73 m\^2, calculated by the modified Modification of Diet in Renal Disease \[MDRD\] formula)
✓. One or more severe renal artery stenoses by any of the following pathways:

Exclusion criteria

✕. Unable to provide informed consent
✕. Unable or willing to comply with study protocol or procedures
✕. Must be greater than 18 years of age
✕. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization
✕. Pregnancy or unknown pregnancy status in female of childbearing potential
✕. Participation in any drug or device trial during the study period, unless approved by the Steering Committee
✕. Prior enrollment in the CORAL study
✕. History of stroke within 6 months, if associated with a residual neurologic deficit\*

What they're measuring

Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy

Timeframe: Measured at every 3 months for the first year and annually thereafter

Cardiovascular or Renal Death

Timeframe: Measured at every 3 months for the first year and annually thereafter

Myocardial Infarction

Timeframe: Measured at every 3 months for the first year and annually thereafter

Hospitalization for Congestive Heart Failure

Timeframe: Measured at every 3 months for the first year and annually thereafter

Stroke

Timeframe: 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

Timeframe: Measured at every 3 months for the first year and annually thereafter

Need for Renal Replacement Therapy

Timeframe: Measured at every 3 months for the first year and annually thereafter

Trial details

NCT IDNCT00081731

SponsorBaim Institute for Clinical Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09

Results submitted2013-12-09

View on ClinicalTrials.gov More Atherosclerosis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Either
✓. Documented history of hypertension on two or more anti-hypertensive medications OR
✓. Renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate \[GFR\] less than 60 mL per minute per 1.73 m\^2, calculated by the modified Modification of Diet in Renal Disease \[MDRD\] formula)
✓. One or more severe renal artery stenoses by any of the following pathways:

Exclusion criteria

✕. Unable to provide informed consent
✕. Unable or willing to comply with study protocol or procedures
✕. Must be greater than 18 years of age
✕. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization
✕. Pregnancy or unknown pregnancy status in female of childbearing potential
✕. Participation in any drug or device trial during the study period, unless approved by the Steering Committee
✕. Prior enrollment in the CORAL study
✕. History of stroke within 6 months, if associated with a residual neurologic deficit\*

What they're measuring

Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy

Timeframe: Measured at every 3 months for the first year and annually thereafter

Cardiovascular or Renal Death

Timeframe: Measured at every 3 months for the first year and annually thereafter

Myocardial Infarction

Timeframe: Measured at every 3 months for the first year and annually thereafter

Hospitalization for Congestive Heart Failure

Timeframe: Measured at every 3 months for the first year and annually thereafter

Stroke

Timeframe: 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

Timeframe: Measured at every 3 months for the first year and annually thereafter

Need for Renal Replacement Therapy

Timeframe: Measured at every 3 months for the first year and annually thereafter