A Prospective, Open Label, Randomized Study to Evaluate Safety And Effectiveness Of The Tivoli® Biodegradable Polymer Rapamycin-Eluting Stent and The FIREBIRD2® Rapamycin-Eluting Coronary CoCr Stent For Treatment Coronary Revascularization

Essen Technology (Beijing) Co., Ltd.1 site in 1 country2,790 target enrollmentSeptember 2012

ConditionsIschemic Heart Disease Myocardial Ischemia Coronary Artery Lesions,Primary Coronary Disease Acute Coronary Syndrome Furcation Lesion of Coronary Artery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ischemic Heart Disease
Sponsor: Essen Technology (Beijing) Co., Ltd.
Enrollment: 2790
Locations: 1
Primary Endpoint: Ischemia-driven Target Lesion Failure (TLF) which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target lesion revascularization (TLR) at 12 months post-procedure.
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multi-center, open label, randomized study to evaluate the efficacy and safety of The TIVOLI Biodegradable polymer Rapamycin-Eluting Stent comparing with The FIREBIRD2™ Rapamycin-eluting Stent (DES) for Treatment Coronary Revascularization.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

September 2018

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Essen Technology (Beijing) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•• The patient must be ≥18 of age;
•Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia including chronic stable coronary artery disease, or acute coronary syndrome including non-ST-elevation and ST-elevation myocardial infarction;
•Acceptable candidate for CABG;
•The patient is willing to comply with specified follow-up evaluations;4.Patients who agree to accept the follow-up visits.
•Patients can understand the study objectives psychologically and linguistically and show the sufficient compliance to the study protocol. Patients present acceptance of the risks and benefits described in the informed consent form.
•Angiographic Inclusion criteria:
•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 2.5 mm to 4.0 mm;
•Patients with multi-lesion or multi-vessel coronary disease, must have successful treatment (\<30% diameter stenosis visual estimate) of the first treated lesion prior to treatment of other lesions at the same brand of stent. Staged (planned) procedures must be performed within 30 days of the index procedure.

Exclusion Criteria

•General Exclusion Criteria
•Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure.
•Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year;
•Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
•Left ventricular function \<40%;
•Cardiogenic shock or hemodynamic compromise requiring pressors and/or inotropes or mechanical support;
•Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, Rapamycinry , styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
•Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
•Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.
•Existing impairment in liver and kidney.

Outcomes

Primary Outcomes

Ischemia-driven Target Lesion Failure (TLF) which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target lesion revascularization (TLR) at 12 months post-procedure.

Time Frame: 12 months