A Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization

Beijing AmsinoMed Medical Device Co., Ltd1 site in 1 country1,200 target enrollmentJuly 2013

ConditionsIschemic Heart Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ischemic Heart Disease
Sponsor: Beijing AmsinoMed Medical Device Co., Ltd
Enrollment: 1200
Locations: 1
Primary Endpoint: Ischemia-driven target lesion failure(iTLF) , including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization.

Detailed Description

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization, 1200 primary coronary artery disease patients will be enrolled, at approximately 40 sites. Subject follow-up will occur via telephone contact or clinical visit at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

April 2021

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing AmsinoMed Medical Device Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient must be at least 18 years of age;
•Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI);
•At least one lesion with a diameter stenosis \>70% or more suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5mm to 3.5mm;
•If the subject has multiple vessel lesions, the implanted stents must be the same brand. The staged procedure only be allowed within 3 months after procedure, the implanted stent must be the same brand stent as the index procedure;
•Subject has no CABG contraindication;
•Subject or legal representative is informed the property of the study, understand the stipulations in the protocol, ensure the compliance and sign the ICF;

Exclusion Criteria

•Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure;
•Subject has a tendency to bleeding or coagulation disorders, or has contraindication of antiplatelet and/or anticoagulant therapy, or can't accept the continue DAPT within 6 months;
•Poor compliance or expectation of life less than 1 year;
•Implanted any brand stent in the same target vessel within 1 year;
•Left Ventricular Ejection Fraction (LVEF) of \<30%;
•Cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support;
•The subject is allergic to asprin, heparin, clopidogrel/ticlopidine, stainless steel alloy, arsenic trioxide, sirolimus, styrene-butene-styrene or polylactic acid(PLA) polymer and contrast agent;
•Severe tortuous and/or heavy calcification lesion;
•Two or more proximal chronic total occlusion lesion;
•Bifurcation lesions with double stents;

Outcomes

Primary Outcomes

Ischemia-driven target lesion failure(iTLF) , including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)

Time Frame: at 12 months post procedure