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

Abbott

Status: Completed

Conditions: Coronary Artery Disease; Ischemic Heart Disease; Myocardial Ischemia; Angina Pectoris

Treatments: Device: XIENCE Xpedition 2.25 mm stent

Study type: Observational

Funder types: Industry

Identifiers

NCT02513732

14-306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria

   1. 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.

   2. 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.

2. Exclusion criteria

   1. 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.
   2. Patients who are attending or will attend other PMS with invasive medical procedure will not be registered.

3. 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.

Trial design

100 participants in 1 patient group

XIENCE Xpedition 2.25 mm stent arm

Description:

Patients receiving XIENCE Xpedition 2.25 mm stent

Treatment:

Device: XIENCE Xpedition 2.25 mm stent