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Coronary Artery Stenting

Phase 1

Coronary Artery Disease | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Oct 20, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

Coronary Artery Stenting · 1 trial · 1 indication

Phase 1 1
NCT00248079The Medtronic RESOLUTE Clinical TrialCoronary Artery Disease
COMPLETED139 Analytics
PHASE1COMPLETED
The Medtronic RESOLUTE Clinical Trial
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)
9 months

Secondary Endpoints

Major adverse cardiac event (MACE) rate
30 days, 4, 6, 9 & 12 months
Acute success (device, lesion, and procedure)
4 or 9 Months
Target vessel failure (TVF)
9 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Coronary Artery StentingDEVICEInitial implant of drug eluting stent (zotarolimus)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patient is at least 18 years old 2. Patient is an acceptable candidate for percutaneous coronary intervention and emergent coronary artery bypass graft surgery 3. Patient has clinical evidence of ischemic heart disease or a positive functional study 4. Female patients of chil...

Countries:Australia
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Frequently asked questions about Coronary Artery Stenting

What is Coronary Artery Stenting used for?

Coronary Artery Stenting is used for the treatment of Coronary Artery Disease. It is an investigational therapy being developed by Medtronic plc. The therapy is currently in Phase 1 clinical development, with one completed clinical trial involving 139 participants in Australia.

Who makes Coronary Artery Stenting?

Coronary Artery Stenting is being developed by Medtronic plc, a medical device company traded on the New York Stock Exchange under the ticker symbol MDT. The therapy is currently in Phase 1 clinical development for the treatment of Coronary Artery Disease.

What phase is Coronary Artery Stenting in?

Coronary Artery Stenting is in Phase 1 clinical development. It is an investigational therapy for Coronary Artery Disease and has not yet been approved by regulatory authorities. One Phase 1 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is Coronary Artery Stenting in?

Coronary Artery Stenting has one completed clinical trial, the Medtronic RESOLUTE Clinical Trial (NCT00248079). This Phase 1 study enrolled 139 participants with Coronary Artery Disease in Australia. The trial was uncontrolled and not randomized or double-blinded.

Is Coronary Artery Stenting the same as the Medtronic RESOLUTE Clinical Trial?

Coronary Artery Stenting is the investigational therapy evaluated in the Medtronic RESOLUTE Clinical Trial, identified by the clinical trial identifier NCT00248079. This Phase 1 study was conducted in Australia and enrolled 139 participants with Coronary Artery Disease.