Clinical trial NCT01249027: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
Official title: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angioplasty
Chronic Coronary Occlusion
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: Drug eluting stents
Stents
China
DES
XIENCE V EECSS
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-11-29
Enrollment: 2605
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General Chinese interventional cardiology population

Brief summary: This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:

* Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
* Evaluate patient compliance to dual antiplatelet therapy (DAPT)


Eligibility criteria: Inclusion Criteria:

* The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
* Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.

Exclusion Criteria:

* The inability to obtain a signed ICF

Primary outcomes:
measure: Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
timeFrame: 0 to 407 days
measure: Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
timeFrame: 0 to 772 days
measure: Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
timeFrame: 0 to 1137 days
measure: Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
timeFrame: 0 to 1502 days
measure: Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
timeFrame: 0 to 1867 days
Secondary outcomes:
measure: Number of Participants With Stent Thrombosis
timeFrame: 0 to 1867 days
measure: Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
timeFrame: 0 to 407 days
measure: Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
timeFrame: 0 to 772 days
measure: Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
timeFrame: 0 to 1137 days
measure: Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
timeFrame: 0 to 1502 days
measure: Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
timeFrame: 0 to 1867 days
measure: Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
timeFrame: 0 to 407 days
measure: Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
timeFrame: 0 to 772 days
measure: Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
timeFrame: 0 to 1137 days
measure: Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
timeFrame: 0 to 1502 days
measure: Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
timeFrame: 0 to 1867 days
measure: Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
timeFrame: 0 to 407 days
measure: Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
timeFrame: 0 to 772 days
measure: Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
timeFrame: 0 to 1137 days
measure: Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
timeFrame: 0 to 1502 days
measure: Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
timeFrame: 0 to 1867 days
measure: Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
timeFrame: 0 to 407 days
measure: Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
timeFrame: 0 to 772 days
measure: Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
timeFrame: 0 to 1137 days
measure: Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
timeFrame: 0 to 1502 days
measure: Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
timeFrame: 0 to 1867 days
measure: Number of Participants With Composite Rate of All Death and Any MI
timeFrame: 0 to 407 days
measure: Number of Participants With Composite Rate of All Death and Any MI
timeFrame: 0 to 772 days
measure: Number of Participants With Composite Rate of All Death and Any MI
timeFrame: 0 to 1137 days
measure: Number of Participants With Composite Rate of All Death and Any MI
timeFrame: 0 to 1502 days
measure: Number of Participants With Composite Rate of All Death and Any MI
timeFrame: 0 to 1867 days
measure: Number of Participants Experiencing Death
timeFrame: 0 to 407 days
measure: Number of Participants Experiencing Death
timeFrame: 0 to 772 days
measure: Number of Participants Experiencing Death
timeFrame: 0 to 1137 days
measure: Number of Participants Experiencing Death
timeFrame: 0 to 1502 days
measure: Number of Participants Experiencing Death
timeFrame: 0 to 1867 days
measure: Number of Participants With Any MI
timeFrame: 0 to 407 days
measure: Number of Participants With Any MI
timeFrame: 0 to 772 days
measure: Number of Participants With Any MI
timeFrame: 0 to 1137 days
measure: Number of Participants With Any MI
timeFrame: 0 to 1502 days
measure: Number of Participants With Any MI
timeFrame: 0 to 1867 days
measure: Number of Participants With Revascularization
timeFrame: 0 to 407 days
measure: Number of Participants With Revascularization
timeFrame: 0 to 772 days
measure: Number of Participants With Revascularization
timeFrame: 0 to 1137 days
measure: Number of Participants With Revascularization
timeFrame: 0 to 1502 days
measure: Number of Participants With Revascularization
timeFrame: 0 to 1867 days
measure: Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
timeFrame: 0 to 407 days
measure: Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
timeFrame: 0 to 772 days
measure: Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
timeFrame: 0 to 1137 days
measure: Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
timeFrame: 0 to 1502 days
measure: Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
timeFrame: 0 to 1867 days
measure: Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
timeFrame: 1 year
measure: Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
timeFrame: 2 years
measure: Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
timeFrame: 3 years
measure: Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
timeFrame: 4 years
measure: Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
timeFrame: 5 years
measure: Number of Participants With All Target Lesions Revascularization
timeFrame: 0 to 407 days
measure: Number of Participants With All Target Lesion Revascularization
timeFrame: 0 to 772 days
measure: Number of Participants With All Target Lesions Revascularization
timeFrame: 0 to 1137 days
measure: Number of Participants With All Target Lesion Revascularization
timeFrame: 0 to 1502 days
measure: Number of Participants With All Target Lesion Revascularization
timeFrame: 0 to 1867 days
measure: Number of Participants With All Target Vessel Revascularization
timeFrame: 0 to 407 days
measure: Number of Participants With All Target Vessel Revascularization
timeFrame: 0 to 772 days
measure: Number of Participants With All Target Vessel Revascularization
timeFrame: 0 to 1137 days
measure: Number of Participants With All Target Vessel Revascularization
timeFrame: 0 to 1502 days
measure: Number of Participants With All Target Vessel Revascularization
timeFrame: 0 to 1867 days
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: Fudan University
name: Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Cardiovascular Guangdong, Guangdong Provincial People's Hospital
name: Jiyan Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: An Zhen Hospital
name: YuJie Zhou, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: