N/A
Completed N=2,009
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
Angina · Chronic Coronary Occlusion · Stent Thrombosis · Vascular disease
Source: ClinicalTrials.gov NCT01086228 ↗
Enrolled (actual)
2,009
Serious AEs
45.3%
Results posted
Feb 2018
Primary outcomePrimary: Number of Participants With Stent Thrombosis (ST) as Per ARC Definition — 6; 2; 6 participants
Summary
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stent Thrombosis (ST) as Per ARC Definition |
0; 0; 4 | — |
| SECONDARY Number of Participants With Adverse Events Related to Anti-platelet Medication |
0; 0; 3; 0; 0; 2 | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
26.1 | — |
| SECONDARY Acute Gain |
1.769; 1.409 | — |
| SECONDARY Late Loss |
0.219; 0.152; 0.034; 0.128 | — |
| SECONDARY Net Gain |
1.536; 1.269 | — |
| SECONDARY Acute Success |
99.94; 0.06 | — |
| SECONDARY Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) |
109 | — |
| SECONDARY Number of Participants With Myocardial Infarctions (MI) |
33 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
104 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
168 | — |
| SECONDARY Number of Participants With Cardiac Death and All MI |
56 | — |
| SECONDARY Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) |
133 | — |
| SECONDARY Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR |
140 | — |
| SECONDARY Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) |
184 | — |
| SECONDARY Number of Participants With All Deaths and All MI |
134 | — |
| SECONDARY Number of Participants With All Deaths, All MI and All Revascularization |
508 | — |
| SECONDARY Number of Participants With All Deaths, TVMI and TLR |
214 | — |
| SECONDARY Number of Participants With All Deaths, TVMI and CI-TLR |
196 | — |
Eligibility Criteria
Inclusion Criteria
- Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Exclusion Criteria
- Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Data sourced from ClinicalTrials.gov (NCT01086228). 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.