Clinical trial NCT01894152: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Official title: Evaluate the Continued Safety and Effectiveness of the XIENCE PRIME EECSS in a Cohort of Real-world Patients Receiving the XIENCE PRIME EECSS During Commercial Use.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angioplasty
Cardiovascular Disease
Coronary Artery Disease
Coronary Heart Disease
Coronary Restenosis
Myocardial Infarction
Stent Thrombosis
Vascular Disease
Keywords: XIENCE PRIME EECSS
XIENCE V EECSS
XIENCE PRIME
SPIRIT PRIME
XIENCE PRIME SV (Small Vessel)
XIENCE PRIME LL (Long Lesion)
Coronary Artery Disease
Coronary Heart Disease
Cardiovascular Disease
Myocardial Infarction
Stent Thrombosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 2002
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in realworld settings in China.

Brief summary: Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.

This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.

This study has no primary outcome measure. All observations are of equal weight.


Eligibility criteria: Inclusion Criteria:

* The patient must be at least 18 years of age at the time of signing the informed consent.
* The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF).
* Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.

Exclusion Criteria:

* No other exclusion criteria are specified for this study.

Primary outcomes:
measure: Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
timeFrame: ≤ 7 days after index procedure (Hospitalization)
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
timeFrame: 0 through 1885 Days
measure: Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
timeFrame: 0 through 1885 Days
measure: Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
timeFrame: 0 through 1885 Days
measure: Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
timeFrame: 0 through 1885 Days
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 0 through 1885 Days
measure: Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
timeFrame: 0 through 1885 Days
measure: Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
timeFrame: 0 through 1885 Days
measure: Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
timeFrame: 0 through 1885 Days
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 0 through 1885 Days
measure: Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
timeFrame: 0 through 1885 Days
measure: Number of Participants With Acute Stent Thrombosis
timeFrame: 0 to 1 day
measure: Number of Participants With Sub-acute Stent Thrombosis
timeFrame: > 1 day to 30 days
measure: Number of Participants With Early Stent Thrombosis
timeFrame: 0 - 30 days
measure: Number of Participants With Late Stent Thrombosis
timeFrame: 31 to 365 days
measure: Number of Participants With Very Late Stent Thrombosis
timeFrame: > 365 days
measure: Number of Participants With Overall Stent Thrombosis
timeFrame: 0 to 1885 days
measure: Number of Participants With Target Vessel ARC MI
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With Target Vessel ARC MI
timeFrame: 0 to 1885 days
measure: Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
timeFrame: 0 to 1885 days
measure: Number of Participants With All TLR
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With All TLR
timeFrame: 0 to 1885 days
measure: Number of Participants With ID-TLR
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With ID-TLR
timeFrame: 0 to 1885 days
measure: Number of Participants With ID-TVR, Non-target Lesion
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With ID-TVR, Non-target Lesion
timeFrame: 0 to 1885 days
measure: Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
timeFrame: ≤ 7 days after index procedure (Hospitalization)
measure: Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
timeFrame: 0 to 1885 days
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: Fudan University
name: Junbo Ge, MB, MSc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anzhen Hospital
name: Fang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: