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Ardian Catheter

Phase 1

End Stage Renal Disease | 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 Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00551304Native Kidney Denervation in Patients With End Stage Renal DiseasePHASE1 COMPLETED - — — Oct 1, 2007 -Nov 6, 20122 Australia, Poland
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Study Endpoints
Primary Endpoints
To provide confirmation that renal denervation in ESRD patients is safe and feasible.
Secondary Endpoints
To provide evidence of denervation, indication of physiologic response, and assess device performance.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Ardian CatheterDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * adult \>= 18 years of age * end stage renal disease, undergoing concurrent dialysis treatment * poorly controlled blood pressure on at least 2 antihypertensive drugs * agrees to have the study procedure(s) performed and additional procedures and evaluations, including interven...

Countries:AustraliaPoland
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