CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,002 enrolled
Drug / intervention
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01894152
NCT01894152N/ACompleted
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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 Medical Devices·observational·Posted Jul 10, 2013·Updated May 26, 2020

In Brief

An observational study evaluating XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) for Angioplasty and 7 related conditions. Completed, enrolled 2,002 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAngioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease, Coronary Restenosis, Myocardial Infarction, Stent Thrombosis, Vascular Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 10, 2013
Enrollment StartJul 1, 2013
Primary CompletionOct 9, 2019
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 13.0 years ago

Interventions

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)device

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