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XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study (XV CHINA SAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01249027
First received: November 24, 2010
Last updated: April 2, 2013
Last verified: April 2013
History of Changes

November 24, 2010
April 2, 2013
November 2010
January 2017   (final data collection date for primary outcome measure)
  • (This study has no primary endpoint, all endpoints are of equal weight). Incidence of the composite rate of cardiac death and any myocardial infarction (MI) (including Q-wave and non-Q-wave) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • (This study has no primary endpoint, all endpoints are of equal weight). Incidence of the composite rate of cardiac death and any myocardial infarction (MI) (including Q-wave and non-Q-wave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • (This study has no primary endpoint, all endpoints are of equal weight). Incidence of the composite rate of cardiac death and any myocardial infarction (MI) (including Q-wave and non-Q-wave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • (This study has no primary endpoint, all endpoints are of equal weight). Incidence of the composite rate of cardiac death and any myocardial infarction (MI) (including Q-wave and non-Q-wave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • (This study has no primary endpoint, all endpoints are of equal weight). Incidence of the composite rate of cardiac death and any myocardial infarction (MI) (including Q-wave and non-Q-wave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01249027 on ClinicalTrials.gov Archive Site
  • Stent thrombosis (definite and probable) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, MI attributed to the target vessel (TV-MI), and target lesion revascularization (TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, MI attributed to the target vessel (TV-MI), and target lesion revascularization (TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, MI attributed to the target vessel (TV-MI), and target lesion revascularization (TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, MI attributed to the target vessel (TV-MI), and target lesion revascularization (TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, MI attributed to the target vessel (TV-MI), and target lesion revascularization (TLR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Any MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Any MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Any MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Any MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Any MI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Major bleeding complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Patient compliance with DAPT [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Dual Anti-platelet Therapy (DAPT)
  • Patient compliance with DAPT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Dual Anti-platelet Therapy (DAPT)
  • Patient compliance with DAPT [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Dual Anti-platelet Therapy (DAPT)
  • Patient compliance with DAPT [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Dual Anti-platelet Therapy (DAPT)
  • Patient compliance with DAPT [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Dual Anti-platelet Therapy (DAPT)
Same as current
Not Provided
Not Provided
 
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

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

General Chinese interventional cardiology population
  • Angioplasty
  • Chronic Coronary Occlusion
  • Stent Thrombosis
  • Vascular Disease
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Observational
Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).
Intervention: Device: XIENCE V® 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.
 
Active, not recruiting
2605
January 2017
January 2017   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01249027
10-388
No
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI Fudan University
Principal Investigator: Jiyan Chen, MD Institute of Cardiovascular Guangdong, Guangdong Provincial People's Hospital
Principal Investigator: YuJie Zhou, MD, Ph.D An Zhen Hospital
Abbott Vascular
April 2013

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