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Renal Denervation with a catheter-based procedure

Phase 1

Kidney Failure, Chronic | Unknown | Nephrology |Medtronic plc.|Last Updated: Nov 6, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00753116Renal Denervation in End Stage Renal Disease Patients With Refractory HypertensionPHASE1 COMPLETED 20Sep 1, 2008Dec 1, 2009Nov 6, 20121 United States
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Study Endpoints
Primary Endpoints
Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.
Through 1 year
Secondary Endpoints
Physiologic response to denervation (e.g., blood pressure reduction)
Through 1 year
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Renal Denervation with a catheter-based procedureDEVICEDisruption of the renal nerves with a catheter-based procedure
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Systolic blood pressure of 160 mmHg or greater * On 3 or more antihypertensive medications * On dialysis for more than 6 months Exclusion Criteria: * Renal artery abnormalities * Known secondary hypertension attributable to a cause other than sleep apnea * MI, angina, CVA wi...

Countries:United States
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