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

Completed

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

In brief

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.

Key facts

Study ID

NCT01894152

Run by

Abbott Medical Devices

People needed

2002

Starts

2013-07-01

Expected to finish

2019-10-09

Last updated by the study team

2020-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

You may not qualify if…

• No other exclusion criteria are specified for this study.

Where it is running

• Abbott Vascular — Santa Clara, California, United States

Full record on ClinicalTrials.gov

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