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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01894152
Recruitment Status : Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Angioplasty Cardiovascular Disease Coronary Artery Disease Coronary Heart Disease Coronary Restenosis Myocardial Infarction Stent Thrombosis Vascular Disease Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Study Design

Study Type : Observational
Actual Enrollment : 2003 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : July 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 1 year ]
  2. Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 2 years ]
  3. Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 3 years ]
  4. Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 4 years ]
  5. Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 5 years ]
  6. Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 1 year ]
  7. Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 2 years ]
  8. Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 3 years ]
  9. Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 4 years ]
  10. Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 5 years ]
  11. Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 1 year ]
  12. Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 2 years ]
  13. Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 3 years ]
  14. Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 4 years ]
  15. Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 5 years ]
  16. Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR) [ Time Frame: 1 year ]
  17. Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR) [ Time Frame: 2 years ]
  18. Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR) [ Time Frame: 3 years ]
  19. Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR) [ Time Frame: 4 years ]
  20. Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR) [ Time Frame: 5 years ]
  21. Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 1 year ]
  22. Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 2 years ]
  23. Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 3 years ]
  24. Stent thrombosis (definite and probable, per Academic Research Consortium [ARC] definition) [ Time Frame: 4 years ]
  25. Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 5 years ]
  26. Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 1 year ]
  27. Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 2 years ]
  28. Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 3 years ]
  29. Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 4 years ]
  30. Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 5 years ]
  31. All MI (including Q-wave and non-Q-wave) [ Time Frame: 1 year ]
  32. All MI (including Q-wave and non-Q-wave) [ Time Frame: 2 years ]
  33. All MI (including Q-wave and non-Q-wave) [ Time Frame: 3 years ]
  34. All MI (including Q-wave and non-Q-wave) [ Time Frame: 4 years ]
  35. All MI (including Q-wave and non-Q-wave) [ Time Frame: 5 years ]
  36. Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 1 year ]
  37. Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 2 years ]
  38. Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 3 years ]
  39. Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 4 years ]
  40. Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894152


Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI Fudan University
Principal Investigator: Fang Chen, MD Anzhen Hospital
More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01894152     History of Changes
Other Study ID Numbers: 12-396
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016

Keywords provided by Abbott Vascular:
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

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Myocardial Infarction
Thrombosis
Vascular Diseases
Coronary Restenosis
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Coronary Stenosis
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents