Coronary Artery Disease Clinical Trial
Official title:
Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2 mm
Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.
The purpose of this postapproval study is to conduct a prospective, multi-center evaluation
of the procedural and clinical outcomes of subjects that are treated with the commercially
available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent
System.
Descriptive statistics and 95% confidence intervals will be calculated for clinically
relevant variables as described in a separate statistical analysis plan.
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