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

NCT01894152 | Completed Results

• 1 other identifier: 12-396
• Study Type: observational
• Target: 2,002
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Angioplasty; Cardiovascular Disease; Coronary Artery Disease; Coronary Heart Disease; Coronary Restenosis; Myocardial Infarction; Stent Thrombosis; Vascular Disease

Keywords

XIENCE PRIME EECSS; XIENCE V EECSS; XIENCE PRIME; SPIRIT PRIME; XIENCE PRIME SV (Small Vessel); XIENCE PRIME LL (Long Lesion); Coronary Artery Disease; Coronary Heart Disease; Cardiovascular Disease; Myocardial Infarction; Stent Thrombosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint

  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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  ≤ 7 days after index procedure (Hospitalization)

Other Outcomes (37)

• Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint

  0 through 1885 Days

• Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints

  ≤ 7 days after index procedure (Hospitalization)

• Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints

  0 through 1885 Days

Study Arms (1)

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Interventions

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) DEVICE

Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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 European Commission (EC)-approved Informed Consent Form (ICF).
• Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Coronary Restenosis; Myocardial Infarction; Vascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Roy Leong
• Organization: Abbott Vascular

roy.leong@abbott.com

+65 (6277) 3202

Study Officials

• Junbo Ge, MB, MSc, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Fang Chen, MD

  Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: July 1, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2013
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: May 26, 2020
• Results First Posted: April 1, 2019

Record last verified: 2020-05

Locations

US (1)