Trials / Completed
CompletedNCT01894152
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,002 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Angioplasty
- Cardiovascular Disease
- Coronary Artery Disease
- Coronary Heart Disease
- Coronary Restenosis
- Myocardial Infarction
- Stent Thrombosis
- Vascular Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2019-10-09
- Completion
- 2019-10-09
- First posted
- 2013-07-10
- Last updated
- 2020-05-26
- Results posted
- 2019-04-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01894152. Inclusion in this directory is not an endorsement.