galaxy rapamycin drug-eluting bioresorbable coronary stent system first-in-man study

Conditions: Heart Diseases

Summary: the galaxy first-in-man study is a small pilot. single arm research , which will enroll a total of 45 patients. the goal is to access the feasibility, safety and efficacy of rapamycin drug-eluting bioresorbable coronary stent system in the treatment of patients with de novo coronary lesion.

this study is a prospective, single arm clinical trial. 45 patients enrolled in the study will be randomly assigned to queue1 (n=30) and queue 2 (n=15). the clinical follow-up will be performed in all subjects at 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after stent implantation; angiographic,ivus and oct follow-up will be performed at 6 months and 2 years after stent implantation in queue 1; angiographic,ivus and oct follow-up will be performed at 1 year and 3 years after stent implantation in queue 2. the primary endpoint of the study is target lesion failure (tlf) at 30 days after stent implantation.

Eligibility criteria:
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; * total number of target lesion is 1; * target lesion must be ≤ 25mm in length (visual estimation) and 3.0 to 3.75 mm in diameter ; * visual assessment of target lesion diameter stenosis ≥ 70%,timi blood flow≥1; * the target lesion can be covered by one stent; * patient must be an acceptable candidate for coronary artery bypass graft; * to understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up. 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 class iii and above) ,left ventricular ejection fraction or \<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; * to 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.