Overview

This trial is active, not recruiting.

Conditions ischemic heart disease, angina pectoris, coronary artery disease, myocardial ischemia
Treatment xience xpedition 2.25 mm stent
Sponsor Abbott Vascular
Start date July 2014
End date March 2021
Trial size 100 participants
Trial identifier NCT02513732, 14-306

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients receiving XIENCE Xpedition 2.25 mm stent
xience xpedition 2.25 mm stent
Patients receiving XIENCE Xpedition 2.25 mm stent

Primary Outcomes

Measure
Stent Thrombosis: acute
time frame: 0-24 hours post stent implantation
Stent Thrombosis: subacute
time frame: >24 hours to 30 days post stent implantation
Stent Thrombosis: late
time frame: 30 days to 1 year post stent implantation
Stent thrombosis: very late
time frame: >1 year post stent implantation

Secondary Outcomes

Measure
Percent Diameter Stenosis (%DS)
time frame: At baseline before procedure
Percent Diameter Stenosis (%DS)
time frame: Participants will be followed post procedure through discharge, an expected duration of 1 week
Percent Diameter Stenosis (%DS)
time frame: 8 months
Thrombolysis In Myocardial Infarction (TIMI) Flow
time frame: At baseline before procedure
Thrombolysis In Myocardial Infarction (TIMI) Flow
time frame: Participants will be followed post procedure through discharge, an expected duration of 1 week
Thrombolysis In Myocardial Infarction (TIMI) Flow
time frame: 8 months
Percentage of participants using antiplatelet therapy
time frame: At baseline before procedure
Percentage of participants using maintenance antiplatelet therapy
time frame: Participants will be followed post procedure through discharge, an expected duration of 1 week
Percentage of participants changing or terminating antiplatelet therapy
time frame: 8 months
Percentage of participants changing or terminating antiplatelet therapy
time frame: 1 year
Percentage of participants changing or terminating antiplatelet therapy
time frame: 2 years
Percentage of participants changing or terminating antiplatelet therapy
time frame: 3 years
Percentage of participants changing or terminating antiplatelet therapy
time frame: 4 years
Percentage of participants changing or terminating antiplatelet therapy
time frame: 5 years
Death
time frame: 8 months
Death
time frame: 1 year
Death
time frame: 2 years
Death
time frame: 3 years
Target lesion revascularization
time frame: 8 months
Target lesion revascularization
time frame: 1 year
Target lesion revascularization
time frame: 2 years
Target lesion revascularization
time frame: 3 years
Target vessel revascularization
time frame: 8 months
Target vessel revascularization
time frame: 1 year
Target vessel revascularization
time frame: 2 years
Target vessel revascularization
time frame: 3 years
Myocardial infarction
time frame: 8 months
Myocardial infarction
time frame: 1 year
Myocardial infarction
time frame: 2 years
Myocardial infarction
time frame: 3 years

Eligibility Criteria

Male or female participants at least 20 years old.

- 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 attending or will attend other PMS with invasive medical procedure will not be registered. - 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. - 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.

Additional Information

Official title XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance
Description Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year. The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Abbott Vascular.