Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization

Not Applicable

• Conditions: Ischemic Heart Disease; Myocardial Ischemia; Coronary Artery Lesions,Primary; Coronary Disease; Acute Coronary Syndrome; Furcation Lesion of Coronary Artery
• Interventions: Device: Tivoli® DES; Device: Firebird2® DES

• Registration Number: NCT01681381
• Lead Sponsor: Essen Technology (Beijing) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-07
• Status Verified: 2012-11
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21
• Primary Completion: 2013-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2790

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.
  • Extremely tortuous and/or calcification lesions.

Angiographic exclusion criteria:

• Two or more chronic total occlusions in the proximal half of the epicardial coronary artery which cannot be recannalized.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Firebird2® DES	Tivoli® DES	Device:Firebird2® DES The Firebird2® rapamycin-eluting stent (Firebird2® DES) is an open cell balloon expandable cobalt chromium stent coated with a biocompatible durable styrene-butylenes-styrene (SBS) polymer containing rapamycin at a dose of 9 micrograms per millimeter of stent length.
Firebird2® DES	Firebird2® DES	Device:Firebird2® DES The Firebird2® rapamycin-eluting stent (Firebird2® DES) is an open cell balloon expandable cobalt chromium stent coated with a biocompatible durable styrene-butylenes-styrene (SBS) polymer containing rapamycin at a dose of 9 micrograms per millimeter of stent length.
Tivoli® DES	Tivoli® DES	Device:Tivoli® DES The Tivoli® DES is an open cell balloon expandable cobalt chromium stent coated with a bio-gradable polymer (PLGA) containing rapamycin at a dose of 8 micrograms per millimeter of stent length.
Tivoli® DES	Firebird2® DES	Device:Tivoli® DES The Tivoli® DES is an open cell balloon expandable cobalt chromium stent coated with a bio-gradable polymer (PLGA) containing rapamycin at a dose of 8 micrograms per millimeter of stent length.

Primary Outcome Measures

Name	Time	Method
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.	12 months

Trial Locations

Locations (1)

The General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, Liaoning, China