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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Abbott Vascular.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249027
First Posted: November 29, 2010
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Abbott Vascular
  Purpose

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)

Condition Intervention
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)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • (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 ]
  • (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 ]
  • (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 ]
  • (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 ]
  • (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 ]

Secondary Outcome Measures:
  • Stent thrombosis (definite and probable) [ Time Frame: 1 year ]
  • Stent thrombosis (definite and probable) [ Time Frame: 2 years ]
  • Stent thrombosis (definite and probable) [ Time Frame: 3 years ]
  • Stent thrombosis (definite and probable) [ Time Frame: 4 years ]
  • Stent thrombosis (definite and probable) [ Time Frame: 5 years ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 1 year ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 2 years ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 3 years ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 4 years ]
  • Incidence of the composite rate of all death, any MI, and any repeat revascularization [ Time Frame: 5 years ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 1 year ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 2 years ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 3 years ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 4 years ]
  • Incidence of the composite rate of cardiac death, TV-MI and ischemia-driven TLR [ Time Frame: 5 years ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 1 year ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 2 years ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 3 years ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 1 year ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 2 years ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 3 years ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 4 years ]
  • Incidence of the composite rate of all death and any MI [ Time Frame: 5 years ]
  • Death [ Time Frame: 1 year ]
  • Death [ Time Frame: 2 years ]
  • Death [ Time Frame: 3 years ]
  • Death [ Time Frame: 4 years ]
  • Death [ Time Frame: 5 years ]
  • Any MI [ Time Frame: 1 year ]
  • Any MI [ Time Frame: 2 years ]
  • Any MI [ Time Frame: 3 years ]
  • Any MI [ Time Frame: 4 years ]
  • Any MI [ Time Frame: 5 years ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 1 year ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 2 years ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 3 years ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 4 years ]
  • Revascularization (target lesion, target vessel, and nontarget vessel) [ Time Frame: 5 years ]
  • Major bleeding complications [ Time Frame: 1 year ]
  • Major bleeding complications [ Time Frame: 2 years ]
  • Major bleeding complications [ Time Frame: 3 years ]
  • Major bleeding complications [ Time Frame: 4 years ]
  • Major bleeding complications [ Time Frame: 5 years ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 4 years ]
  • Incidence of the composite rate of cardiac death, all MI and target vessel revascularization (TVR) [ Time Frame: 5 years ]
  • Patient compliance with DAPT [ Time Frame: 1 year ]
    Dual Anti-platelet Therapy (DAPT)

  • Patient compliance with DAPT [ Time Frame: 2 years ]
    Dual Anti-platelet Therapy (DAPT)

  • Patient compliance with DAPT [ Time Frame: 3 years ]
    Dual Anti-platelet Therapy (DAPT)

  • Patient compliance with DAPT [ Time Frame: 4 years ]
    Dual Anti-platelet Therapy (DAPT)

  • Patient compliance with DAPT [ Time Frame: 5 years ]
    Dual Anti-platelet Therapy (DAPT)


Enrollment: 2605
Study Start Date: November 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General Chinese interventional cardiology population
Criteria

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
  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): NCT01249027


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: Jiyan Chen, MD Institute of Cardiovascular Guangdong, Guangdong Provincial People's Hospital
Principal Investigator: YuJie Zhou, MD, Ph.D An Zhen Hospital
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01249027     History of Changes
Other Study ID Numbers: 10-388
First Submitted: November 24, 2010
First Posted: November 29, 2010
Last Update Posted: October 12, 2017
Last Verified: October 2015

Keywords provided by Abbott Vascular:
Drug eluting stents
Stents
China
DES
XIENCE V EECSS

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