To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Late lumen loss, in stent
Late lumen loss measured by quantitative coronary angiography (QCA)
Time frame: 9 months (m)
Major Adverse Cardiac Events (MACE)
Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Death
All death
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Myocardial infarction
All MI, and Target Vessel Myocardial Infarction (TVMI)
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
All revascularizations
Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Target Vessel Failure (TVF)
TVF
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Target Lesion Failure (TLF)
TLF
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Stent Thrombosis (ST)
ST
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
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Device Success
The attainment of \<50% residual stenosis of the target lesion using only the assigned device. The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Time frame: At the end of index procedure, an expected average of 3 days
Lesion Success
The attainment of \<50% residual stenosis of the target lesion using any percutaneous method. The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory.
Time frame: At the end of index procedure, an expected average of 3 days
Procedure Success
The attainment of \<50% residual stenosis of the target lesion and no in-hospital MACE. The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory.
Time frame: Duration of hospital stay, an expected average of 5 days
In-stent and in-segment percent diameter stenosis (%DS)
In-stent and in-segment percent diameter stenosis (%DS)
Time frame: 9 months
In-stent and in-segment binary restenosis rate
In-stent and in-segment binary restenosis rate
Time frame: 9 months
In-stent and in-segment minimal luminal diameter (MLD)
In-stent and in-segment minimal luminal diameter (MLD)
Time frame: 9 months
In-segment late luminal loss
In-segment late luminal loss
Time frame: 9 months