Trial · NCT00081731

Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions

NCT00081731, Phase 3, Completed, Baim Institute for Clinical Research; results first posted 2014-01-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions. Trials, record NCT00081731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00081731

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions
NCT number: NCT00081731
Status: Completed
Phases: Phase 3
Enrollment: 947 participants, actual
Lead sponsor: Baim Institute for Clinical Research
Conditions: Atherosclerosis, Cardiovascular Diseases, Hypertension, Renovascular, Renal Artery Obstruction
Interventions: Atacand/HCT, Caduet, GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)
First posted: 2004-04-21
Last updated: 2015-10-05
Results first posted: 2014-01-29
Limitations and caveats: Patients could be enrolled in the trial with renal artery stenosis \> = 60%. Didn't include patients with fibromuscular dysplasia. Some screened and deemed to be eligible were not enrolled because of physician preference.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy	Measured at every 3 months for the first year and annually thereafter	participants	NUMBER
PRIMARY	Cardiovascular or Renal Death	Measured at every 3 months for the first year and annually thereafter	participants	NUMBER
PRIMARY	Myocardial Infarction	Measured at every 3 months for the first year and annually thereafter	participants	NUMBER
PRIMARY	Hospitalization for Congestive Heart Failure	Measured at every 3 months for the first year and annually thereafter	participants	NUMBER
PRIMARY	Stroke	Measured at every 3 months for the first year and annually thereafter	participants	NUMBER
PRIMARY	30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days	Measured at every 3 months for the first year and annually thereafter	participants	NUMBER
PRIMARY	Need for Renal Replacement Therapy	Measured at every 3 months for the first year and annually thereafter	participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy	Optimal Medical Therapy	169	0.76 to 1.17	participants
Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy	Stenting	161	0.76 to 1.17	participants
Cardiovascular or Renal Death	Optimal Medical Therapy	20		participants
Cardiovascular or Renal Death	Stenting	20		participants
Myocardial Infarction	Optimal Medical Therapy	27		participants
Myocardial Infarction	Stenting	30		participants
Hospitalization for Congestive Heart Failure	Optimal Medical Therapy	26		participants
Hospitalization for Congestive Heart Failure	Stenting	27		participants
Stroke	Optimal Medical Therapy	16		participants
Stroke	Stenting	12		participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Optimal Medical Therapy	480
Overall Study	STARTED	Stenting	467
Overall Study	COMPLETED	Optimal Medical Therapy	472
Overall Study	COMPLETED	Stenting	459
Overall Study	NOT COMPLETED	Optimal Medical Therapy	8
Overall Study	NOT COMPLETED	Stenting	8

Source ClinicalTrials.gov

Adverse events46

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Blood and Lymphatic System Disorders	Blood and lymphatic system disorders	Optimal Medical Therapy	93	472	93
other	Blood and Lymphatic System Disorders	Blood and lymphatic system disorders	Stenting	85	459	85
other	Cardiac Disorders	Cardiac disorders	Optimal Medical Therapy	205	472	205
other	Cardiac Disorders	Cardiac disorders	Stenting	201	459	201
other	Ear and Labyrinth Disorders	Ear and labyrinth disorders	Optimal Medical Therapy	24	472	24
other	Ear and Labyrinth Disorders	Ear and labyrinth disorders	Stenting	32	459	32
other	Eye Disorders	Eye disorders	Optimal Medical Therapy	63	472	63
other	Eye Disorders	Eye disorders	Stenting	60	459	60
other	General Disorders	General disorders	Optimal Medical Therapy	261	472	261
other	General Disorders	General disorders	Stenting	251	459	251

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Optimal Medical Therapy
Total, all-cause mortality	Stenting
Total, other adverse events	Optimal Medical Therapy	441	472
Total, other adverse events	Stenting	429	459
Total, serious adverse events	Optimal Medical Therapy	283	472
Total, serious adverse events	Stenting	290	459

Source ClinicalTrials.gov

Papers11

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16221898	BACKGROUND	PubMed
16824832	BACKGROUND	PubMed
24245566	DERIVED	PubMed
24245567	RESULT	PubMed
24325931	DERIVED	PubMed
24903387	DERIVED	PubMed
26653621	DERIVED	PubMed
27647847	DERIVED	PubMed
30962703	DERIVED	PubMed
34183258	DERIVED	PubMed

1 to 10 of 11

See all 11 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL071556	CORAL: Clinical Coordinating Center	COOPER, CHRISTOPHER J	UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2004 to 2013

Source NIH RePORTER

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Optimal Medical Therapy vs Stenting: 30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days	Trial comparisons
Optimal Medical Therapy vs Stenting: Cardiovascular or Renal Death	Trial comparisons
Optimal Medical Therapy vs Stenting: Hospitalization for Congestive Heart Failure	Trial comparisons
Optimal Medical Therapy vs Stenting: Myocardial Infarction	Trial comparisons
Optimal Medical Therapy vs Stenting: Stroke	Trial comparisons
Optimal Medical Therapy vs Stenting: Need for Renal Replacement Therapy	Trial comparisons
Optimal Medical Therapy vs Stenting: Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy	Trial comparisons
Optimal Medical Therapy vs Stenting: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00081731

GET https://conductscience.org/api/trials/v1/NCT00081731/events?page=2

API reference For AI assistants