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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
  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:

U.S. FDA Resources

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 ] [ 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 ]

Secondary Outcome Measures:
  • 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)


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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01249027     History of Changes
Other Study ID Numbers: 10-388
Study First Received: November 24, 2010
Last Updated: April 2, 2013
Health Authority: China: Food and Drug Administration

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 Occlusion
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
 Embolism and Thrombosis
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013