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 range20 Years

SexALL

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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.

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

View on ClinicalTrials.gov More Ischemic Heart Disease trials