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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ingrid Abrahamsen, MS, Harvard University
ClinicalTrials.gov Identifier:
NCT00081731
First received: April 19, 2004
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: December 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Optimal Medical Therapy

Optimal anti-hypertensive therapy

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

Stenting

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


Participant Flow:   Overall Study
    Optimal Medical Therapy     Stenting  
STARTED     480     467  
COMPLETED     472     459  
NOT COMPLETED     8     8  
scientific integrity issue                 8                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Optimal Medical Therapy

Optimal anti-hypertensive therapy

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

Stenting

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 Total of all reporting groups

Baseline Measures
    Optimal Medical Therapy     Stenting     Total  
Number of Participants  
[units: participants]
  472     459     931  
Age  
[units: years]
Mean ± Standard Deviation
  69  ± 9.0     69.3  ± 9.4     69.15  ± 9.2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     140     127     267  
>=65 years     332     332     664  
Gender  
[units: participants]
     
Female     241     225     466  
Male     231     234     465  
Region of Enrollment  
[units: participants]
     
United States     387     385     772  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   Cardiovascular or Renal Death   [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]

3.  Primary:   Myocardial Infarction   [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]

4.  Primary:   Hospitalization for Congestive Heart Failure   [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]

5.  Primary:   Stroke   [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]

6.  Primary:   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 ]

7.  Primary:   Need for Renal Replacement Therapy   [ Time Frame: Measured at every 3 months for the first year and annually thereafter ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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:  
Name/Title: Christopher Cooper, MD
Organization: University of Toledo
phone: 419-383-6297
e-mail: christopher.cooper@utoledo.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Ingrid Abrahamsen, MS, Harvard University
ClinicalTrials.gov Identifier: NCT00081731     History of Changes
Other Study ID Numbers: 161, U01 HL71556
Study First Received: April 19, 2004
Results First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration