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

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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)

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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