CompletedNot Applicable

XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)

Japan100 participantsStarted 2014-07

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Stent Thrombosis: Late

Timeframe: 30 days to 1 year post stent implantation-Day 212

Trial details

NCT IDNCT02513732

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-09

Results submitted2018-09-27

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