To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
525
Core size includes a range of stent sizes.
Long lesion stent sizes include a range of sizes.
Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time frame: 1 year
Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time frame: 2 years
Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time frame: 3 years
Procedure Time
Procedure time is defined as time between insertion and withdrawal of guide catheter.
Time frame: From insertion to withdrawal of guide catheter
Device Success (Lesion Basis)
Device success is defined as achievement of a final in-stent residual diameter stenosis of \< 50% (by QCA).
Time frame: From the start of index procedure to end of index procedure
Procedural Success (Subject Basis)
Procedure success is defined as achievement of a final in-stent diameter stenosis of \< 50% (by QCA). Per Protocol.
Time frame: From the start of index procedure to end of index procedure
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: In-hospital is less than or equal to 7 days post index procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Thomas Hospital
Fairhope, Alabama, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
Mercy General Hospital
Sacramento, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
St. Vincents Medical Center
Jacksonville, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Sacred Heart Hospital of Pensicola
Pensacola, Florida, United States
St. John's Hospital
Springfield, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
...and 52 more locations
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 30 days
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 180 days
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 1 year
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 2 years
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 3 years
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 30 days
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 180 days
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 1 year
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 2 years
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 3 years
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 30 days
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 180 days
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 1 year
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 2 years
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 3 years
Clinically Indicated-Target Lesion Revascularization
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Clinically Indicated-Target Lesion Revascularization
Time frame: 30 days
Clinically Indicated-Target Lesion Revascularization
Time frame: 180 days
Clinically Indicated-Target Lesion Revascularization
Time frame: 1 year
Clinically Indicated-Target Lesion Revascularization
Time frame: 2 years
Clinically Indicated-Target Lesion Revascularization
Time frame: 3 years
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 30 days
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 180 days
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 1 year
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 2 years
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 3 years
All TLR (CI and Non-CI)
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
All TLR (CI and Non-CI)
Time frame: 30 days
All TLR (CI and Non-CI)
Time frame: 180 days
All TLR (CI and Non-CI)
Time frame: 1 year
All TLR (CI and Non-CI)
Time frame: 2 years
All TLR (CI and Non-CI)
Time frame: 3 years
All TVR (CI and Non-CI)
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
All TVR (CI and Non-CI)
Time frame: 30 days
All TVR (CI and Non-CI)
Time frame: 180 days
All TVR (CI and Non-CI)
Time frame: 1 year
All TVR (CI and Non-CI)
Time frame: 2 years
All TVR (CI and Non-CI)
Time frame: 3 years
All Coronary Revascularization (TVR and Non-TVR)
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 30 days
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 180 days
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 1 year
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 2 years
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 3 years
Cardiac Death/All MI
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Cardiac Death/ All MI
Per Protocol
Time frame: 30 days
Cardiac Death/All MI
Per Protocol
Time frame: 180 days
Cardiac Death/All MI
Per Protocol
Time frame: 1 year
Cardiac Death/All MI
Per Protocol
Time frame: 2 years
Cardiac Death/All MI
Per Protocol
Time frame: 3 years
Cardiac Death/ All MI/CI-TLR
Time frame: in-hospital
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 30 days
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 180 days
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 1 year
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 2 years
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 3 years
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 30 days
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 180 days
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 1 year
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 2 years
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 3 years
Stent Thrombosis
Per protocol and per Academic Research Consortium (ARC, definite/probable)
Time frame: Acute (≤1 day)
Stent Thrombosis
Per protocol and per ARC
Time frame: Subacute (>1 - 30 days)
Stent Thrombosis
Per protocol and per ARC
Time frame: Acute/Subacute (0 - 30 days)
Stent Thrombosis
Per protocol and per ARC
Time frame: Late (31 - 393 days)
Stent Thrombosis
Per protocol
Time frame: Late (31 - 758 days)
Stent Thrombosis
Per ARC, definite and probable
Time frame: Very Late (394 - 758 days)
Stent Thrombosis
Per protocol
Time frame: Late (31 - 1123 days)
Stent Thrombosis
Per ARC, definite and probable
Time frame: Very Late (394 - 1123 days)
Stent Thrombosis
Per protocol and per ARC
Time frame: Overall (0-393 days)
Stent Thrombosis
Per protocol
Time frame: Overall (0-758 days)
Stent Thrombosis
Per ARC, definite and probable
Time frame: Overall (0-758 days)
Stent Thrombosis
Per protocol
Time frame: Overall (0 - 1123 days)
Stent Thrombosis
Per ARC, definite and probable
Time frame: Overall (0 - 1123 days)