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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Abbott Vascular
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01894152
First received: July 1, 2013
Last updated: January 6, 2014
Last verified: January 2014

July 1, 2013
January 6, 2014
July 2013
July 2014   (final data collection date for primary outcome measure)
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01894152 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in realworld settings in China.

  • Angioplasty
  • Cardiovascular Disease
  • Chronic Coronary Occlusion
  • Coronary Artery Bypass Graft (CABG)
  • Coronary Artery Disease
  • Coronary Heart Disease
  • Coronary Restenosis
  • Myocardial Infarction
  • Myocardial Ischemia
  • Stent Thrombosis
  • Vascular Disease
Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Intervention: Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
July 2019
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Roy Leong +65 62773202 roy.leong@abbott.com
United States
 
NCT01894152
12-396
No
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI Fudan University
Principal Investigator: Yundai Chen, MD, PhD Chinese PLA General Hospital
Principal Investigator: Fang Chen, MD Anzhen Hospital
Abbott Vascular
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP