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Medtronic Talent Stent-Graft-System

Phase 3

Aortic Diseases | Unknown | Cardiovascular |Medtronic plc.|Trials Updated: Oct 29, 2015

Medtronic Talent Stent-Graft-System development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Sep 2007

Medtronic Talent Stent-Graft-System target and mechanism

ModalityUnknown

Also known as Endograft

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Medtronic Talent Stent-Graft-System clinical trials

Medtronic Talent Stent-Graft-System · 1 trial · 1 indication

Phase 3 1
NCT00525356INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic DissectionAortic Diseases
COMPLETED136 Analytics
PHASE3COMPLETED
INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
Aortic Diseases
NCT00525356136
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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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