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
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Cardiovascular Diseases
Hypertension, Renovascular
Renal Artery Obstruction
Drug: Atacand/HCT, Caduet
Procedure: GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)

Resource links provided by NLM:


Further study details as provided by Harvard University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Only the first event per participant is included in the composite

  • Cardiovascular or Renal Death [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
  • Hospitalization for Congestive Heart Failure [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Need for Renal Replacement Therapy [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]

Enrollment: 947
Study Start Date: April 2004
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Optimal Medical Therapy
Optimal anti-hypertensive therapy
Drug: Atacand/HCT, Caduet
Atacand/HCT and caduet or optimal medical therapy for hypertension
Experimental: Stenting
Stent procedure plus optimal anti-hypertensive therapy
Procedure: GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)
Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Either

    1. Documented history of hypertension on two or more anti-hypertensive medications OR
    2. 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)
  2. One or more severe renal artery stenoses by any of the following pathways:

    a. Angiographic: greater than or equal to 60% and less than 100% by renal angiogram OR b. Duplex: systolic velocity of greater than 300 cm/sec OR c. Core Lab approved Magnetic Resonance Angiogram (MRA) (refer to the protocol for specific criteria) demonstrating stenosis greater than 80% OR stenosis greater than 70% with spin dephasing on 3D phase contrast MRA OR stenosis greater than 70% and two of the following: i. Ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Ischemic kidney enhances less on arterial phase iii. Ischemic kidney has delayed Gd excretion iv. Ischemic kidney hyper-concentrates the urine v. 2-D phase contrast flow waveform shows delayed systolic peak vi. Post-stenotic dilatation d. Clinical index of suspicion combined with a Core Lab approved Computed Tomography Angiography (CTA) demonstrating Stenosis is greater than 80% by visual assessment on high quality CTA Stenosis is greater than 70% on CTA by visual assessment and there are two of the following i. The length of the ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Reduced cortical thickness of ischemic kidney iii. Less cortical enhancement of ischemic kidney on arterial phase iv. Post-stenotic dilatation

EXCLUSION CRITERIA:

  1. Unable to provide informed consent
  2. Unable or willing to comply with study protocol or procedures
  3. Must be greater than 18 years of age
  4. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization
  5. Pregnancy or unknown pregnancy status in female of childbearing potential
  6. Participation in any drug or device trial during the study period, unless approved by the Steering Committee
  7. Prior enrollment in the CORAL study
  8. History of stroke within 6 months, if associated with a residual neurologic deficit*
  9. Any major surgery, major trauma, revascularization procedure, unstable angina, or myocardial infarction 30 days prior to study entry*
  10. Any planned major surgery or revascularization procedure, outside of the randomly allocated renal stenting indicated by the protocol, after randomization*
  11. Hospitalization for heart failure within 30 days*
  12. Comorbid condition causing life expectancy of less than or equal to 3 years*
  13. Allergic reaction to intravascular contrast, not amenable to pre-treatment
  14. Allergy to stainless steel
  15. Allergy to all of the following: aspirin, clopidogrel, ticlopidine
  16. Known untreated aneurysm of the abdominal aorta greater than 5.0 cm.*
  17. Previous kidney transplant
  18. a. Stenosis of greater than 50% of a previously treated revascularized renal artery OR b. Treatment of any renal artery stenosis within the past 9 months (roll-in patients can have prior treatment on the contralateral side)
  19. Kidney size less than 7 cm. supplied by target vessel
  20. Hydronephrosis, nephritis or other known cause of renal insufficiency, not due to large vessel renal artery stenosis
  21. Visualized stenosis of only an accessory renal artery supplying greater than 1/2 of the ipsilateral renal parenchyma, without stenosis in a dominant renal artery
  22. Local lab serum Cr greater than 4.0 mg/dl on the day of randomization*
  23. Presence of a renal artery stenosis not amenable for treatment with a stent, known to be present prior to randomization

    1. The index lesion cannot be treated with a single stent (i.e. greater than 18 mm. in length)
    2. The placement of a stent will necessitate covering a renal artery branch renal artery with a stent
    3. The stenosis is in an artery less than 3.5 mm. in diameter
    4. The stenosis involves a segmental renal artery branch
  24. Abrupt vessel closure or dissection after diagnostic angiography [NOTE: Patients with abrupt vessel closure or dissection as a result of diagnostic angiography will not be randomized but will undergo stent revascularization, receive optimal medical therapy and will be followed for the full study period] *Roll-in patients do not need to meet these inclusion/exclusion criteria
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00081731

Locations
United States, Ohio
University of Toledo
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
Harvard University
Investigators
Principal Investigator: David Cohen, MD Mid-America Heart Institute, St. Luke's Hospital, Kansas City, MO
Principal Investigator: Christopher J. Cooper, MD University of Toledo
Principal Investigator: Donald Cutlip, MD Beth Israel Deaconess Medcial Center
Principal Investigator: Alan Matsumoto, MD University of Virginia School of Medicine
Principal Investigator: Michael Steffes, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Timothy P Murphy, MD Rhode Island Hospital
Study Chair: Scott D Solomon, MD Brigham and Women's Hospital
Study Chair: Lance D Dworkin, MD Rhode Island Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ingrid Abrahamsen, MS, Project Coordinator, 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

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Hypertension
Hypertension, Renovascular
Renal Artery Obstruction
Arterial Occlusive Diseases
Arteriosclerosis
Vascular Diseases
Hypertension, Renal
Kidney Diseases
Urologic Diseases
Candesartan cilexetil
Amlodipine, atorvastatin drug combination
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on July 24, 2014