A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II

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• General Inclusion Criteria:
• 18-75 years of age, males or non-pregnant females;
• With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
• Patients with indications for coronary artery bypass graft surgery;
• To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
  • Angiographic Inclusion Criteria:
• One or two de novo target lesions:
  • If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
  • If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
  • The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
• Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow reserve, stress test), unstable angina or post-infarct angina. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.5 mm and ≤4.0 mm. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 25 mm.
• Each target lesion may be covered with one stent.
  • General Exclusion Criteria:
• Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
• Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;
• Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <40% (ultrasound or left ventricular angiography);
• Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
• Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
• Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
• The patient's life expectancy is less than 12 months;
• Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
• Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
• Heart transplantation patients;
• The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
• Cancer need chemotherapy;
• Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
• Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
• Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
• Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; known or suspected liver disease (such as hepatitis);
• Peripheral vascular disease, 6F catheter is not available.
  • Angiographic Exclusion Criteria:
• left main coronary artery disease;
• severe triple vessel lesion and required revascularization.
  • The following exclusion criteria apply to the target lesion(s) or target vessel(s):
• Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
• Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD) or left circumflex artery (LCX).
• Lesion involving a bifurcation with a:
  • side branch ≥ 2.5 mm in diameter, or
  • side branch with diameter stenosis ≥ 50%, or
  • side branch requiring guide wire, or
  • side branch requiring dilatation.
• Anatomy proximal to or within the lesion that may impair delivery of Firesorb or XIENCE stent:
  • Extreme angulation (≥ 90°) proximal to or within the target lesion.
  • Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
  • Moderate or heavy calcification proximal to or within the target lesion.
• Lesion or vessel involves a myocardial bridge.
• Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
• Vessel has been previously treated with a stent at any time prior to the index procedure such that the Firesorb or XIENCE would need to cross the stent to reach the target lesion.
• Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
• Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
  • Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly recommended.
  • TIMI Grade-3 flow (per visual estimation).
  • No angiographic complications (e.g. distal embolization, side branch closure).
  • No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F.
  • No chest pain lasting > 5 minutes.
  • No ST depression or elevation lasting > 5 minutes.