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

NCT01249027 | Completed Results

• 1 other identifier: 10-388
• Study Type: observational
• Target: 2,605
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Angioplasty; Chronic Coronary Occlusion; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

Drug eluting stents; Stents; China; DES; XIENCE V EECSS

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)

  Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  0 to 407 days

• Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)

  Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  0 to 772 days

• Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)

  Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  0 to 1137 days

• Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)

  Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  0 to 1502 days

• Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)

  Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  0 to 1867 days

Secondary Outcomes (61)

• Number of Participants With Stent Thrombosis

  0 to 1867 days

• Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization

  0 to 407 days

• Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization

  0 to 772 days

• Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization

  0 to 1137 days

• Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization

  0 to 1502 days

Study Arms (1)

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)

Interventions

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) DEVICE

Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.

Observational

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General Chinese interventional cardiology population

You may qualify if:

• 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.

You may not qualify if:

• The inability to obtain a signed ICF

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

Vascular Diseases; Myocardial Ischemia; Coronary Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Leong Roy
• Organization: Abbott Vascular

roy.leong@abbott.com

8133 7475

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 29, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 1, 2019
• Results First Posted: March 1, 2019

Record last verified: 2018-10

Locations

US (1)