NCT02513732

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

XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ischemic Heart Disease
• Angina Pectoris
• Coronary Artery Disease
• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	XIENCE Xpedition 2.25 mm stent	Patients receiving XIENCE Xpedition 2.25 mm stent

Timeline

• Start date: 2014-07-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2015-08-03
• Last updated: 2021-05-13
• Results posted: 2019-02-21

Locations

11 sites across 1 country: Japan