N/A
Completed N=100
XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)
Source: ClinicalTrials.gov NCT02513732 ↗Enrolled (actual)
100
Serious AEs
63.0%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With Stent Thrombosis: Late — 1 Participants
Summary
The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stent Thrombosis: Late |
1 | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
32.14 | — |
| SECONDARY Number of Participants Using Antiplatelet Therapy |
23; 1; 52; 23; 4; 1 | — |
| SECONDARY Number of Participants With Death |
9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization Based on Ischemia Findings |
6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
1 | — |
| SECONDARY Number of Participants With Cardiac Death |
— | — |
| SECONDARY Number of Participants With MI Related to Target Vessel |
— | — |
| SECONDARY Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) |
50 | — |
| SECONDARY Number of Participants With All Revascularization |
44 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
11 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (Non-TLR) |
13 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) |
24 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) |
8 | — |
| SECONDARY Number of Participants With Death/All MI |
11 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI |
2 | — |
| SECONDARY Number of Participants With Cardiac Death or Target-Vessel MI |
— | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) |
6 | — |
| SECONDARY Mean Acute Gain: In-stent, In-segment |
1.51; 1.20 | — |
| SECONDARY Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal |
0.28; 0.03; -0.06; 0.20 | — |
| SECONDARY Mean Net Gain: In-stent, In-segment |
1.26; 1.04 | — |
| SECONDARY Mean Lesion Length |
17.38 | — |
| SECONDARY Minimum Blood Vessel Diameter |
1.54 | — |
| SECONDARY Mean Reference Vessel Diameter (RVD) |
2.28 | — |
Eligibility Criteria
- Inclusion 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.
- Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered.
- The observations will be compiled on a per-patient basis even if multiple XIENCE Xpedition 2.25mm stents are implanted during the index procedure.
- A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be registered. In such a case, main vessel should be treated by XIENCE Xpedition.
- The observations will not be compiled on a per-patient basis if a patient is treated by XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose.
- 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 Xpedition 2.25mm stent and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the Xpedition stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE Xpedition 2.25mm stent is not required.
- Exclusion criteria
- 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 attending or will attend other PMS with invasive medical procedure will not be registered.
- A patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion.
Data sourced from ClinicalTrials.gov (NCT02513732). 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.