The purpose of this study is to document the safety and overall clinical performance of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a patient population with long lesion(s) and/or dual vessels requiring stent implantation.
A total of 249 to 411 patients will be enrolled from Asia at approximately 25 centers where Endeavor Resolute stent is commercially available. There are two study cohorts: 1. 38 mm cohort: a minimum of 46 patients and maximum of 111 patients with at least one lesion amenable to treatment with a 38 mm length Endeavor Resolute stent. Patients may have one or two lesions, if the two lesions are located in separate target vessels. 2. Dual vessel cohort: a minimum of 203 patients and maximum of 300 patients with dual vessel treatment where each vessel has a lesion with length ≤ 27 mm and reference vessel diameters between 2.25 mm and 4.0 mm.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation
The Heart Care Clinic
Ahmedabad, Gujarat, India
Target Lesion Failure (TLF) for 38mm cohort and Target Vessel Failure (TVF) for dual vessel cohort
TLF is defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. TVF is defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target vessel revascularization (TVR).
Time frame: 12 months
Death
Death rate in the study.
Time frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr
MI
Myocardial infarction (MI) rate in the study.
Time frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr
Cardiac death and MI
Cardiac death and myocardial infarction (MI) rate in the study
Time frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr
MACE
MACE composite endpoint and each individual component (death, myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods)
Time frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr
TLF
TLF composite endpoint and each individual component (cardiac death, target vessel MI or clinically-driven TLR)
Time frame: For 38mm cohort it is 30d, 6m, 9m, 18m, 2yr and 3yr. For dual vessel cohort it is 30d, 6m, 9m, 12m, 18m, 2yr and 3yr
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