XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study (XP China SAS)

May 7, 2020 updated by: Abbott Medical Devices

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2002

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Clara, California, United States, 95054
        • Abbott Vascular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
Time Frame: ≤ 7 days after index procedure (Hospitalization)

Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Myocardial Infarction (MI):

  • Q wave MI: Development of new, pathological Q wave on the ECG.
  • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
Time Frame: 0 through 1885 Days

Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Myocardial Infarction (MI):

  • Q wave MI: Development of new, pathological Q wave on the ECG.
  • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
Time Frame: ≤ 7 days after index procedure (Hospitalization)

All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.

Myocardial Infarction (MI):

  • Q wave MI: Development of new, pathological Q wave on the ECG.
  • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
Time Frame: 0 through 1885 Days

All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.

Myocardial Infarction (MI):

  • Q wave MI: Development of new, pathological Q wave on the ECG.
  • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
Time Frame: ≤ 7 days after index procedure (Hospitalization)

Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.

  • Q wave MI: Development of new, pathological Q wave on the ECG.
  • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
Time Frame: 0 through 1885 Days

Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.

  • Q wave MI: Development of new, pathological Q wave on the ECG.
  • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
Time Frame: ≤ 7 days after index procedure (Hospitalization)

All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.

Myocardial Infarction (MI):

  • Q wave MI: Development of new, pathological Q wave on the ECG.
  • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
Time Frame: 0 through 1885 Days

All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.

Myocardial Infarction (MI):

  • Q wave MI: Development of new, pathological Q wave on the ECG.
  • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of Participants With Target Lesion Failure (TLF)
Time Frame: ≤ 7 days after index procedure (Hospitalization)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With Target Lesion Failure (TLF)
Time Frame: 0 through 1885 Days

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
Time Frame: ≤ 7 days after index procedure (Hospitalization)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR).

This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
Time Frame: 0 through 1885 Days

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR).

This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
Time Frame: ≤ 7 days after index procedure (Hospitalization)

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight.

- Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
Time Frame: 0 through 1885 Days

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight.

- Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Time Frame: ≤ 7 days after index procedure (Hospitalization)

Myocardial Infarction (MI)

  • Q wave MI Development of new, pathological Q wave on the ECG
  • Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Time Frame: 0 through 1885 Days

Myocardial Infarction (MI)

  • Q wave MI Development of new, pathological Q wave on the ECG
  • Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of Participants With All Target Vessel Revascularization (TVR)
Time Frame: ≤ 7 days after index procedure (Hospitalization)

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With All Target Vessel Revascularization (TVR)
Time Frame: 0 through 1885 Days

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 through 1885 Days
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
Time Frame: ≤ 7 days after index procedure (Hospitalization)

This study has no primary or secondary endpoints, all endpoints are of equal weight.

All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
≤ 7 days after index procedure (Hospitalization)
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
Time Frame: 0 through 1885 Days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
0 through 1885 Days
Number of Participants With Acute Stent Thrombosis
Time Frame: 0 to 1 day

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
0 to 1 day
Number of Participants With Sub-acute Stent Thrombosis
Time Frame: > 1 day to 30 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
> 1 day to 30 days
Number of Participants With Early Stent Thrombosis
Time Frame: 0 - 30 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
0 - 30 days
Number of Participants With Late Stent Thrombosis
Time Frame: 31 to 365 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
31 to 365 days
Number of Participants With Very Late Stent Thrombosis
Time Frame: > 365 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
> 365 days
Number of Participants With Overall Stent Thrombosis
Time Frame: 0 to 1885 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
0 to 1885 days
Number of Participants With Target Vessel ARC MI
Time Frame: ≤ 7 days after index procedure (Hospitalization)

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Myocardial Infarction (MI):

Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With Target Vessel ARC MI
Time Frame: 0 to 1885 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Myocardial Infarction (MI):

Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
0 to 1885 days
Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
Time Frame: ≤ 7 days after index procedure (Hospitalization)

This study has no primary or secondary endpoints, all endpoints are of equal weight.

All TVR (TLR and TVR, non-target lesion)
≤ 7 days after index procedure (Hospitalization)
Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
Time Frame: 0 to 1885 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

All TVR (TLR and TVR, non-target lesion)
0 to 1885 days
Number of Participants With All TLR
Time Frame: ≤ 7 days after index procedure (Hospitalization)
This study has no primary or secondary endpoints, all endpoints are of equal weight.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With All TLR
Time Frame: 0 to 1885 days
This study has no primary or secondary endpoints, all endpoints are of equal weight.
0 to 1885 days
Number of Participants With ID-TLR
Time Frame: ≤ 7 days after index procedure (Hospitalization)

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Revascularization includes TLR, TVR, non-target lesion, and non TVR.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With ID-TLR
Time Frame: 0 to 1885 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Revascularization includes TLR, TVR, non-target lesion, and non TVR.
0 to 1885 days
Number of Participants With ID-TVR, Non-target Lesion
Time Frame: ≤ 7 days after index procedure (Hospitalization)

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Revascularization includes TLR, TVR, non-target lesion, and non TVR.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With ID-TVR, Non-target Lesion
Time Frame: 0 to 1885 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Revascularization includes TLR, TVR, non-target lesion, and non TVR.
0 to 1885 days
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
Time Frame: ≤ 7 days after index procedure (Hospitalization)

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Revascularization includes TLR, TVR, non-target lesion, and non TVR.
≤ 7 days after index procedure (Hospitalization)
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
Time Frame: 0 to 1885 days

This study has no primary or secondary endpoints, all endpoints are of equal weight.

Revascularization includes TLR, TVR, non-target lesion, and non TVR.
0 to 1885 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junbo Ge, MB, MSc, MD, Fudan University
  • Principal Investigator: Fang Chen, MD, Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12-396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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