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stent implantation

Phase 3

Acute Coronary Syndrome | Unknown | Cardiovascular |Cardio Diagnostics Holdings Inc.|Last Updated: May 23, 2012

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical trial landscape

stent implantation · 1 trial · 1 indication

Phase 3 1
NCT01239654Activity of Platelets After Inhibition and Cardiovascular Events Optical Coherence Tomography StudyAcute Coronary Syndrome
COMPLETED60 Analytics
PHASE3COMPLETED
Activity of Platelets After Inhibition and Cardiovascular Events Optical Coherence Tomography Study
Acute Coronary SyndromeUnlock trial analytics
Study Endpoints
Primary Endpoints
Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS.
6 month

Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS. The degree of neointimal coverage will be assessed using optical coherence tomography (OCT) calculating the rate of exposed stent struts in the study stents.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
everolimusACTIVE_COMPARATOReverolimus-eluting stent
zotarolimusACTIVE_COMPARATORzotarolimus-eluting stent
Interventions
NameTypeDescription
stent implantationDEVICEimplantation of everolimus-eluting stent vs zotarolimus-eluting stent
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Diagnosis of ACS and clinical indication to PCI * Presence of 1 or more de novo stenosis equal or greater than 70% in native coronary arteries. * Patient is \> 18 years of age (or minimum age as required by local regulations). * The patient has consented to participate by sign...

Countries:Italy
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