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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

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Clinical trial landscape

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 DiseasesUnlock trial analytics

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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Frequently asked questions about Medtronic Talent Stent-Graft-System

What is the Medtronic Talent Stent-Graft-System used for?

The Medtronic Talent Stent-Graft-System is used for aortic diseases, specifically in the treatment of patients with type B aortic dissection. It is an investigational device being studied in a Phase 3 clinical trial to evaluate its safety and effectiveness in this patient population.

Who makes the Medtronic Talent Stent-Graft-System?

The Medtronic Talent Stent-Graft-System is developed by Rhythm Pharmaceuticals, Inc. (ticker: RYTM). The company is conducting clinical research on this device for the treatment of aortic diseases.

What phase is the Medtronic Talent Stent-Graft-System in?

The Medtronic Talent Stent-Graft-System is in Phase 3 clinical development. It is an investigational device and has not been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its use in patients with type B aortic dissection.

What clinical trials is the Medtronic Talent Stent-Graft-System in?

The Medtronic Talent Stent-Graft-System was studied in the INSTEAD Trial (NCT00525356), a Phase 3, active-controlled, randomized study. The trial enrolled 136 patients with aortic diseases in the Netherlands and has been completed.

Is the Medtronic Talent Stent-Graft-System the same as the INSTEAD trial device?

The Medtronic Talent Stent-Graft-System is the device evaluated in the INSTEAD Trial (NCT00525356), which stands for INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection. The trial compared the stent-graft system against an active control in 136 patients.