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

Abbott

Status: Completed

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

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01894152

12-396

Details and patient eligibility

About

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.

Enrollment: 2,002 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• No other exclusion criteria are specified for this study.

Trial design

2,002 participants in 1 patient group

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Description:

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

Treatment:

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