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Medtronic Talent Stent-Graft-System

Phase 3

Aortic Diseases | Unknown | Cardiovascular |Rhythm Pharmaceuticals, Inc.|Last Updated: Oct 29, 2015

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment136
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00525356INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic DissectionPHASE3 COMPLETED 136Feb 1, 2002Sep 1, 2007Oct 29, 20151 Netherlands
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Study Endpoints
Primary Endpoints
all-cause mortality
1 year
Secondary Endpoints
thrombosis of the false lumen, cardiovascular morbidity, degree of aortic expansion, length of intensive care and hospital stay, and quantitative assessment of single or combination antihypertensive drug therapy.
5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORAnti-hypertensive medical treatment
Interventions
NameTypeDescription
Medtronic Talent Stent-Graft-SystemDEVICE -
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * No contraindication for an anesthetic procedure with intubation * Type B aortic dissection that occurred 2-52 weeks before randomization * Diameter of the targeted aortic segment ≤6 cm * Aortic kinking \<75° * The subject or legal guardian understands the nature of the study a...

Countries:Netherlands
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