Renal Artery Disease - RENAL DENVERATION
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Trial Sponsor
Ardian Inc.
Principal Investigator
Krishna Rocha-Singh, MD
Trial Name
Renal Denervation in Patients With Refractory Hypertension.
Purpose
The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.
Phase
Phase I
Study Type
Interventional
Study Design
Treatment, Non-Randomized, Open Label, Single Group Assignment
Study Arms
1
Expected Enrollment
20
Study Start
September 2008
Expected Completion
December 2009
Primary Outcome Measures
- Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events out to 1 year.
Secondary Outcome Measures
- Physiologic response to renal denervation (e.g., blood pressure reduction) out to 1 year.
Eligibility
Ages Eligible for Study
18 years or older
Genders Eligible for Study
Both
Inclusion Criteria
- Systolic blood pressure of 160 mmHg or greater
- On 3 or more antihypertensive medications
- eGFR >= 45 mL/min
Exclusion Criteria
- Renal artery abnormalities
- Known secondary hypertension attributable to a cause other than sleep apnea
- MI, angina, CVA within 6 months
- Type 1 diabetes
- Others
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