Clinical trial NCT01681381: Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Myocardial Ischemia
Coronary Artery Lesions,Primary
Coronary Disease
Acute Coronary Syndrome
Furcation Lesion of Coronary Artery
Lead sponsor: Essen Technology (Beijing) Co., Ltd.
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 2790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
  * 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military Region
state: Liaoning
Study officials:
affiliation: The General Hospital of Shenyang Military Region
name: Han Yaling, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han Y, Xu B, Xu K, Guan C, Jing Q, Zheng Q, Li X, Zhao X, Wang H, Zhao X, Li X, Yu P, Zang H, Wang Z, Cao X, Zhang J, Pang W, Li J, Yang Y, Dangas GD. Six Versus 12 Months of Dual Antiplatelet Therapy After Implantation of Biodegradable Polymer Sirolimus-Eluting Stent: Randomized Substudy of the I-LOVE-IT 2 Trial. Circ Cardiovasc Interv. 2016 Feb;9(2):e003145. doi: 10.1161/CIRCINTERVENTIONS.115.003145.
citation: Han Y, Xu B, Jing Q, Lu S, Yang L, Xu K, Li Y, Li J, Guan C, Kirtane AJ, Yang Y; I-LOVE-IT 2 Investigators. A randomized comparison of novel biodegradable polymer- and durable polymer-coated cobalt-chromium sirolimus-eluting stents. JACC Cardiovasc Interv. 2014 Dec;7(12):1352-60. doi: 10.1016/j.jcin.2014.09.001. Epub 2014 Nov 12.