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



Status:Active, not recruiting
Conditions:Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:July 2013
End Date:September 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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.


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.
We found this trial at
1
site
Abbott Vascular
Santa Clara, California 95054
?
mi
from
Santa Clara, CA
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