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A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization

2014-07-24 14:00:45 | BioPortfolio

Summary

This is a prospective, multi-center registry to evaluate safety and effectiveness of the Everolimus Drug Eluting Stent for treatment coronary revascularization in Chinese patients with long lesion, small vessel or multi-vessel diseases.

Description

Study Device:The XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V EECSS or XIENCE V stent system) is a device/drug combination product consisting of either the MULTI-LINK VISION® Coronary Stent System or the MULTI-LINK MINI VISION® Coronary Stent System coated with a formulation containing everolimus, the active ingredient, embedded in a non-erodible polymer. Design:A prospective, multi-center, registry that is designed to enroll Chinese patients with either Long Lesion, or Small Vessel or Multi-Vessel diseases. Purpose:To evaluate the safety and effectiveness of the XIENCE V® everolimus drug eluting stent for coronary revascularization of patients with either long lesion, or small vessel, or multi-vessel diseases. Enrollment:Approximately 1900 patients will be enrolled in at least 45 but up to 51 centers. Mainland China 41 up to 47 centers, Taiwan China 3 centers and Macao China 1 center. This registry is planned to enroll at least 50% of patients with multi-vessel disease. Primary Endpoint:Ischemia-driven Target Vessel Failure (TVF) which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target vessel revascularization (TVR) at 12 months post-index procedure. Follow-Up Visits:30 days, 6 months, 12 months, and 24 months post index procedure.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Coronary Artery Diseases

Intervention

Everolimus Drug Eluting Stent, Aspirin, Clopidogrel, Heparin or Bivalirudin

Location

Fuwai Hospital
Beijing
China

Status

Recruiting

Source

CCRF Consulting Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:00:45-0400

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