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Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions (CORAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00081731
Recruitment Status : Completed
First Posted : April 21, 2004
Results First Posted : January 29, 2014
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Baim Institute for Clinical Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atherosclerosis
Cardiovascular Diseases
Hypertension, Renovascular
Renal Artery Obstruction
Interventions Drug: Atacand/HCT, Caduet
Procedure: GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)
Enrollment 947
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Period Title: Overall Study
Started 480 467
Completed 472 459
Not Completed 8 8
Reason Not Completed
scientific integrity issue             8             8
Arm/Group Title Optimal Medical Therapy Stenting Total
Hide Arm/Group Description

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Total of all reporting groups
Overall Number of Baseline Participants 472 459 931
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 472 participants 459 participants 931 participants
69  (9.0) 69.3  (9.4) 69.15  (9.2)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 472 participants 459 participants 931 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
140
  29.7%
127
  27.7%
267
  28.7%
>=65 years
332
  70.3%
332
  72.3%
664
  71.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 472 participants 459 participants 931 participants
Female
241
  51.1%
225
  49.0%
466
  50.1%
Male
231
  48.9%
234
  51.0%
465
  49.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 472 participants 459 participants 931 participants
387 385 772
1.Primary Outcome
Title Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy
Hide Description Only the first event per participant is included in the composite
Time Frame Measured at every 3 months for the first year and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description:

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Overall Number of Participants Analyzed 472 459
Measure Type: Number
Unit of Measure: participants
169 161
2.Primary Outcome
Title Cardiovascular or Renal Death
Hide Description [Not Specified]
Time Frame Measured at every 3 months for the first year and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description:

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Overall Number of Participants Analyzed 472 459
Measure Type: Number
Unit of Measure: participants
20 20
3.Primary Outcome
Title Myocardial Infarction
Hide Description [Not Specified]
Time Frame Measured at every 3 months for the first year and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description:

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Overall Number of Participants Analyzed 472 459
Measure Type: Number
Unit of Measure: participants
27 30
4.Primary Outcome
Title Hospitalization for Congestive Heart Failure
Hide Description [Not Specified]
Time Frame Measured at every 3 months for the first year and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description:

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Overall Number of Participants Analyzed 472 459
Measure Type: Number
Unit of Measure: participants
26 27
5.Primary Outcome
Title Stroke
Hide Description [Not Specified]
Time Frame Measured at every 3 months for the first year and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description:

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Overall Number of Participants Analyzed 472 459
Measure Type: Number
Unit of Measure: participants
16 12
6.Primary Outcome
Title 30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days
Hide Description [Not Specified]
Time Frame Measured at every 3 months for the first year and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description:

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Overall Number of Participants Analyzed 472 459
Measure Type: Number
Unit of Measure: participants
77 68
7.Primary Outcome
Title Need for Renal Replacement Therapy
Hide Description [Not Specified]
Time Frame Measured at every 3 months for the first year and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description:

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Overall Number of Participants Analyzed 472 459
Measure Type: Number
Unit of Measure: participants
3 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Optimal Medical Therapy Stenting
Hide Arm/Group Description

Optimal anti-hypertensive therapy

Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension

Stent procedure plus optimal anti-hypertensive therapy

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

All-Cause Mortality
Optimal Medical Therapy Stenting
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Optimal Medical Therapy Stenting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   283/472 (59.96%)      290/459 (63.18%)    
Blood and lymphatic system disorders     
Blood and Lymphatic System Disorders  1  11/472 (2.33%)  11 16/459 (3.49%)  16
Cardiac disorders     
Cardiac Disorders  1  117/472 (24.79%)  117 128/459 (27.89%)  128
Congenital, familial and genetic disorders     
Congenital, Familial and Genetic Disorders  1  1/472 (0.21%)  1 0/459 (0.00%)  0
Ear and labyrinth disorders     
Ear and Labyrinth Disorders  1  5/472 (1.06%)  5 1/459 (0.22%)  1
Eye disorders     
Eye Disorders  1  3/472 (0.64%)  3 2/459 (0.44%)  2
Gastrointestinal disorders     
Gastrointestinal Disorders  1  42/472 (8.90%)  42 57/459 (12.42%)  57
General disorders     
General Disorders  1  38/472 (8.05%)  38 36/459 (7.84%)  36
Hepatobiliary disorders     
Hepatobiliary Disorders  1  7/472 (1.48%)  7 5/459 (1.09%)  5
Immune system disorders     
Immune System Disorders  1  0/472 (0.00%)  0 1/459 (0.22%)  1
Infections and infestations     
Infections and Infestations  1  69/472 (14.62%)  69 63/459 (13.73%)  63
Injury, poisoning and procedural complications     
Injury, Poisoning and Procedural Complications  1  19/472 (4.03%)  19 42/459 (9.15%)  42
Investigations     
Investigations  1  1/472 (0.21%)  1 4/459 (0.87%)  4
Metabolism and nutrition disorders     
Metabolism and Nutrition Disorders  1  28/472 (5.93%)  28 19/459 (4.14%)  19
Musculoskeletal and connective tissue disorders     
Musuloskeletal and Connective Tissue Disorders  1  31/472 (6.57%)  31 39/459 (8.50%)  39
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant and Unspecified  1  26/472 (5.51%)  26 27/459 (5.88%)  27
Nervous system disorders     
Nervous System Disorders  1  67/472 (14.19%)  67 61/459 (13.29%)  61
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Optimal Medical Therapy Stenting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   441/472 (93.43%)      429/459 (93.46%)    
Blood and lymphatic system disorders     
Blood and Lymphatic System Disorders  1  93/472 (19.70%)  93 85/459 (18.52%)  85
Cardiac disorders     
Cardiac Disorders  1  205/472 (43.43%)  205 201/459 (43.79%)  201
Ear and labyrinth disorders     
Ear and Labyrinth Disorders  1  24/472 (5.08%)  24 32/459 (6.97%)  32
Eye disorders     
Eye Disorders  1  63/472 (13.35%)  63 60/459 (13.07%)  60
General disorders     
General Disorders  1  261/472 (55.30%)  261 251/459 (54.68%)  251
Injury, poisoning and procedural complications     
Injury, Poisoning and Procedural Complications  1  122/472 (25.85%)  122 133/459 (28.98%)  133
Investigations     
Investigations  1  125/472 (26.48%)  125 124/459 (27.02%)  124
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Cooper, MD
Organization: University of Toledo
Phone: 419-383-6297
EMail: christopher.cooper@utoledo.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Baim Institute for Clinical Research
ClinicalTrials.gov Identifier: NCT00081731    
Other Study ID Numbers: 161
U01HL071556 ( U.S. NIH Grant/Contract )
First Submitted: April 19, 2004
First Posted: April 21, 2004
Results First Submitted: December 9, 2013
Results First Posted: January 29, 2014
Last Update Posted: October 5, 2015