N/A
Completed N=312
XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)
Heart Failure · Angina Pectoris · Coronary Artery Disease · Coronary Artery Occlusion
Source: ClinicalTrials.gov NCT02513719 ↗
Enrolled (actual)
312
Serious AEs
52.9%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Stent Thrombosis: Acute — 1 Participants
Summary
The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stent Thrombosis: Acute |
1 | — |
| PRIMARY Number of Participants With Stent Thrombosis: Subacute |
— | — |
| PRIMARY Number of Participants With Stent Thrombosis: Late |
1 | — |
| SECONDARY Number of Participants With Stent Thrombosis: Very Late |
— | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
28.31 | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
28.31 | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
28.31 | — |
| SECONDARY Success Rate: Percentage of Devices With Implant Success |
100 | — |
| SECONDARY Success Rate: Percentage of Lesions With Procedural Success |
100 | — |
| SECONDARY Success Rate: XIENCE PRIME Implant Success by Patient |
100 | — |
| SECONDARY Number of Death |
30 | — |
| SECONDARY Number of Death |
30 | — |
| SECONDARY Number of Death |
30 | — |
| SECONDARY Number of Death |
30 | — |
| SECONDARY Number of Death |
30 | — |
| SECONDARY Number of Death |
30 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
5 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
5 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
5 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
5 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
5 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
5 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization |
27 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization |
27 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization |
27 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization |
27 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization |
27 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization |
27 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR) |
51 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR) |
51 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR) |
51 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR) |
51 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR) |
51 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR) |
51 | — |
| SECONDARY Number of Participants With Non-target Vessel Revascularization (Non-TVR) |
58 | — |
| SECONDARY Number of Participants With Non-target Vessel Revascularization (Non-TVR) |
58 | — |
| SECONDARY Number of Participants With Non-target Vessel Revascularization (Non-TVR) |
58 | — |
| SECONDARY Number of Participants With Non-target Vessel Revascularization (Non-TVR) |
58 | — |
| SECONDARY Number of Participants With Non-target Vessel Revascularization (Non-TVR) |
58 | — |
| SECONDARY Number of Participants With Non-target Vessel Revascularization (Non-TVR) |
58 | — |
| SECONDARY Number of Participants With All Revascularization |
88 | — |
| SECONDARY Number of Participants With All Revascularization |
88 | — |
| SECONDARY Number of Participants With All Revascularization |
88 | — |
| SECONDARY Number of Participants With All Revascularization |
88 | — |
| SECONDARY Number of Participants With All Revascularization |
88 | — |
| SECONDARY Number of Participants With All Revascularization |
88 | — |
| SECONDARY Number of Participants With Hemorrhage |
4 | — |
| SECONDARY Number of Participants With Hemorrhage |
4 | — |
| SECONDARY Number of Participants With Hemorrhage |
4 | — |
| SECONDARY Number of Participants With Hemorrhage |
4 | — |
| SECONDARY Number of Participants With Hemorrhage |
4 | — |
| SECONDARY Number of Participants With Hemorrhage |
4 | — |
| SECONDARY Number of Participants With Target Lesion Failure |
25 | — |
| SECONDARY Number of Participants With Target Lesion Failure |
25 | — |
| SECONDARY Number of Participants With Target Lesion Failure |
25 | — |
| SECONDARY Number of Participants With Target Lesion Failure |
25 | — |
| SECONDARY Number of Participants With Target Lesion Failure |
25 | — |
| SECONDARY Number of Participants With Target Lesion Failure |
25 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization |
111 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization |
111 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization |
111 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization |
111 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization |
111 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization |
111 | — |
| SECONDARY Number of Participants With Target Vessel Failure |
45 | — |
| SECONDARY Number of Participants With Target Vessel Failure |
45 | — |
| SECONDARY Number of Participants With Target Vessel Failure |
45 | — |
| SECONDARY Number of Participants With Target Vessel Failure |
45 | — |
| SECONDARY Number of Participants With Target Vessel Failure |
45 | — |
| SECONDARY Number of Participants With Target Vessel Failure |
45 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE) |
28 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE) |
28 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE) |
28 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE) |
28 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE) |
28 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE) |
28 | — |
| SECONDARY Number of Participants With Death or MI |
33 | — |
| SECONDARY Number of Participants With Death or MI |
33 | — |
| SECONDARY Number of Participants With Death or MI |
33 | — |
| SECONDARY Number of Participants With Death or MI |
33 | — |
| SECONDARY Number of Participants With Death or MI |
33 | — |
| SECONDARY Number of Participants With Death or MI |
33 | — |
| SECONDARY Number of Participants With Cardiac Death or MI |
12 | — |
| SECONDARY Number of Participants With Cardiac Death or MI |
12 | — |
| SECONDARY Number of Participants With Cardiac Death or MI |
12 | — |
| SECONDARY Number of Participants With Cardiac Death or MI |
12 | — |
| SECONDARY Number of Participants With Cardiac Death or MI |
12 | — |
| SECONDARY Number of Participants With Cardiac Death or MI |
12 | — |
| SECONDARY Number of Participants With Cardiac Death or Target-Vessel MI |
4 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel-MI |
5 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI |
9 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI |
9 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI |
9 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI |
9 | — |
| SECONDARY Acute Gain: In-stent,In-segment |
1.56; 1.16 | — |
| SECONDARY Late Loss(LL): In-stent,In-segment,Proximal, and Distal |
0.23; 0.13; -0.03; 0.09 | — |
| SECONDARY Net Gain: In-stent, In-segment |
1.31; 1.08 | — |
Eligibility Criteria
- Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed.
- If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.
- Patients who are treated (stent delivery system inserted into the body) by XIENCE PRIME SV will be registered (including provisional stenting for side branch treatment but excluding bail-out only use).
- The observations will be compiled on a per-patient basis even if multiple stents are implanted during the index procedure.
- A patient whose side-branch is treated by XIENCE PRIME SV can be registered. In such a case, main vessel should be treated by XIENCE PRIME.
- A patient who are treated by other drug eluting stent (DES) for planned stent and XIENCE PRIME SV for bail-out purpose cannot be registered.
- Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events.
- A patient who is treated, but failed to be implanted by XIENCE PRIME SV and finally treated by other devices only (No XIENCE PRIME SV are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the PRIME stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE PRIME SV stent is not required.
- A patient may have another lesion(s) that may be treated by larger diameter stent(s). In such a case, treatment by XIENCE PRIME is preferable. Lesion(s) treated by other than XIENCE PRIME is not considered as the target lesion.
Data sourced from ClinicalTrials.gov (NCT02513719). 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.