Jason T. Lee
Treatment on subject with renal artery narrowing with the use of approved peripheral stents and blood pressure medication as compared to blood pressure medication alone.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305 VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Brief
This study is designed to compare the safety and effectiveness of treating one's renal artery narrowing with the use of approved peripheral stents and blood pressure medication as compared to blood pressure medication alone.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Antihypertensive drugs
- Procedure: Renal artery angioplasty and stenting
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Either:
a. Documented history of hypertension on 2 or more anti-hypertensive medications OR
b. Renal dysfunction defined as Stage 3 or greater CKD based on the new NKF classifications (estimated GFR < 60 mL per minute per 1.73 m2 calculated by the modified MDRD formula)
2. One or more severe renal artery stenoses by any of the following pathways:
a. Angiographic: >= 60% and < 100% by renal angiogram OR
b. Duplex: systolic velocity of >= 300 cm/sec OR
c. Core lab approved MRA demonstrating
- Stenosis > 90%
- Stenosis > 75% with spin dephasing on 3D phase contrast MRA OR
- Stenosis > 75% and two of the following:
i. Ischemic kidney is > 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.
Key Exclusion Criteria:
1. Unable to provide informed consent
2. Unable or unwilling to comply with study protocol or procedures
3. Age <18
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 (women of child-bearing
age/ability be required to undergo a pregnancy test before enrolling in the study)
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 dictated by this protocol, after randomization
11. Hospitalization for heart failure within 30 days
12. Comorbid condition causing life expectancy <= 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 > 5.0 cm
17. Previous kidney transplant
18. Stenosis of > 50% of a previously treated revascularized renal artery or 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 < 1/2 of the ipsilateral renal parenchyma,
without stenosis in a dominant renal artery
22. Local lab serum Cr > 3.0 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
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.]
Additional Study Details
Official Title:
CORAL: Cardiovascular Outcomes in Renal Atherosclerotic LesionsAnticipated start date:
3/13/2007Lead Sponsor:
The University of ToledoInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Event-free survival from cardiovascular and renal adverse events defined as a composite of cardiovascular or renal death, stroke, MI, hospitalization for CHF, progressive renal insufficiency, or need for permanent renal replacement therapy.
Secondary Outcomes:
- all cause mortality
Total Number to be Enrolled:
1080Total Number to be Enrolled at Stanford:
20More Information
Publications About this Study:
- 16824832: Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: rationale and design of the CORAL trial.
- 16221898: The Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study: rationale and methods.
Secondary ID(s):
- IRB eprotocol number: 7631
- SPO number: 34972
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305 VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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