The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
The purpose and objective is 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(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
St. Joseph's Hospital Health Center
Syracuse, New York, United States
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
Time frame: 12 months
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI
Time frame: 12 months
Clinical Endpoint: Death
Time frame: 12 months
Dual Antiplatelet Therapy (DAPT) Compliance
Time frame: 12 months
Clinical Endpoint: TLR
Time frame: 12 months
Clinical Endpoint: TVR
Time frame: 12 months
Clinical Endpoint: MI
Time frame: 12 months
Clinical Endpoint: ST
Time frame: 12 months
Clinical Endpoint: Stroke
Time frame: 12 months
Clinical Endpoint: Bleeding Complications in General
Time frame: 12 months
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