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

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ClinicalTrials.gov Identifier: NCT01681381
Recruitment Status : Unknown
Verified November 2012 by Essen Technology (Beijing) Co., Ltd..
Recruitment status was:  Recruiting
First Posted : September 7, 2012
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Essen Technology (Beijing) Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Myocardial Ischemia Coronary Artery Lesions,Primary Coronary Disease Acute Coronary Syndrome Furcation Lesion of Coronary Artery Device: Tivoli® DES Device: Firebird2® DES Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Device: Tivoli® DES
Device:Tivoli® DES The Tivoli® DES drug eluting stent(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. In vitro assays have shown that about 50% of the drug releasing in 1 week and approximately 80% releasing in 28 days. The polymer may be degraded in 3 to 6 months in human body. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 10、15、18、21、25、30、35 mm and diameters of 2.5、2.75、3.0、3.5、4.0 mm.

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. In vitro assays have shown that about 50% of the drug elutes in 1 week and approximately 90% elutes in 1 month. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 13, 18, 23, 29, 33 mm and diameters of 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm.
Experimental: 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.
 Device: Tivoli® DES
Device:Tivoli® DES The Tivoli® DES drug eluting stent(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. In vitro assays have shown that about 50% of the drug releasing in 1 week and approximately 80% releasing in 28 days. The polymer may be degraded in 3 to 6 months in human body. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 10、15、18、21、25、30、35 mm and diameters of 2.5、2.75、3.0、3.5、4.0 mm.

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. In vitro assays have shown that about 50% of the drug elutes in 1 week and approximately 90% elutes in 1 month. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 13, 18, 23, 29, 33 mm and diameters of 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
    • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681381


Locations
China, Liaoning
The General Hospital of Shenyang Military Region Recruiting
Shenyang, Liaoning, China, 86-110016
Contact: Han Yaling, Prof.    (86-024) 28851120    hanyaling@263.net   
Principal Investigator: Han Yaling, Prof.         
Sponsors and Collaborators
Essen Technology (Beijing) Co., Ltd.
Investigators
Principal Investigator: Han Yaling, Prof. The General Hospital of Shenyang Military Region
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Essen Technology (Beijing) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01681381     History of Changes
Other Study ID Numbers: I-LOVE-IT2
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: November 2012

Additional relevant MeSH terms:
Heart Diseases
Ischemia
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Everolimus
 Cobalt
Chromium
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances