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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

ALL

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

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