Coronary Artery Disease Clinical Trial
Official title:
The Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease
To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic (previously unstented) lesions in native coronary arteries in subjects with coronary artery disease (CAD) having a reference vessel diameter (RVD) between 2.5 - 4.0 mm and a lesion length ≤ 26 mm amenable to percutaneous coronary intervention (PCI) with a single stent in subjects with symptomatic ischemic heart disease.
Safety and Efficacy will be demonstrated by the rate of Target vessel failure (TVF), defined
as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave], or
clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods
within 270 days of the post-stent placement procedure.
Additionally, Major Adverse Cardiac Events (MACE)at 30, 180 and 270 days defined as a
composite of all-cause death, myocardial infarction (MI) (Q wave and non-Q wave), emergent
bypass surgery, or clinically driven target lesion revascularization (TLR) [percutaneous
coronary intervention (PCI) or coronary artery bypass graft (CABG)]will be documented.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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