N/A
Completed N=2,482
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
Angioplasty · Chronic Coronary Occlusion · Stent Thrombosis · Vascular disease
Source: ClinicalTrials.gov NCT01249027 ↗
Enrolled (actual)
2,482
Serious AEs
23.1%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) — 33 Participants
Summary
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:
* Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
* Evaluate patient compliance to dual antiplatelet therapy (DAPT)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) |
84 | — |
| SECONDARY Number of Participants With Stent Thrombosis |
5; 10 | — |
| SECONDARY Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization |
271 | — |
| SECONDARY Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) |
95 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) |
35 | — |
| SECONDARY Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) |
93 | — |
| SECONDARY Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) |
136 | — |
| SECONDARY Number of Participants With Composite Rate of All Death and Any MI |
137 | — |
| SECONDARY Number of Participants Experiencing Death |
113 | — |
| SECONDARY Number of Participants With Any MI |
31 | — |
| SECONDARY Number of Participants With Revascularization |
154 | — |
| SECONDARY Number of Participants With Major Bleeding Complications (According to GUSTO Classification) |
18 | — |
| SECONDARY Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) |
800 | — |
| SECONDARY Number of Participants With All Target Lesions Revascularization |
25 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization |
33 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization |
60 | — |
Eligibility Criteria
Inclusion Criteria
- The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
- Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.
Exclusion Criteria
- The inability to obtain a signed ICF
Data sourced from ClinicalTrials.gov (NCT01249027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.