NCT01157455

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

Clinical Trial Program of a Medical Instrument Product

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,900 (estimated)
• Sponsor: CCRF Consulting Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Diseases

Interventions

Type	Name	Description
PROCEDURE	Everolimus Drug Eluting Stent	Implantation
DRUG	Aspirin	Orally take by 300mg per day at least within 24 hours before index procedure. Orally 100mg indefinitely after the procedure as a part of dual anti-platelet therapy
DRUG	Clopidogrel	A loading dose of 300mg must be given at least 6 hours prior to index procedure, or a loading dose of 75mg/d 72 hours prior to index procedure. 75mg daily for at least 12 months after the procedure as a part of dual anti-platelet therapy.
DRUG	Heparin or Bivalirudin	During procedure or in-hospital, Heparin 100u/kg or Bivalirudin may be given,or follow up the standard practice of each site.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-03-01
• Completion: 2013-06-01
• First posted: 2010-07-07
• Last updated: 2010-07-12

Locations

1 site across 1 country: China