a first-in-man study of ibs

Conditions: Single Coronary Vessel Disease

Summary: the study is a pilot clinical trial for sirolimus-eluting iron bioresorbable coronary scaffold system（ibs）. the main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of ibs. to provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of ibs.

a prospective, single-center, first-in-man trial; study population: 45 subjects. 45 subjects will be randomly assigned into two cohorts: cohort 1(n=30), cohort 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, 5 years post procedure; the angiographic, intra-vascular ultrasound (ivus) and optical coherence tomography (oct) will be performed at 6 months and 2 years post procedure in cohort 1. the angiographic, ivus and oct will be performed at 1 year and 3 years post procedure in cohort 2. the primary study endpoints: 1. target lesion failure (tlf) at 6 months post procedure 2. late lumen loss at 6 months post procedure

Eligibility criteria:
inclusion criteria: all patients participating in this clinical trial must meet the following criteria: 1. age of 18-75, males or non pregnancy females; 2. subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective pci; 3. one target lesion, and target lesion can be completely covered by a single stent; 4. target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual); 5. visual assessment of target lesion stenosis ≥70%, timi blood flow≥ 1; 6. subject who understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up. exclusion criteria: patients will be excluded if any of the following conditions apply: general: 1. within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal; 2. implantation of stent in target vessel within 1 year, patients with planned intervention again within six months; 3. patients who had coronary artery bypass (coronary artery bypass grafting); 4. patients with contraindications for coronary artery bypass graft surgery; 5. severe heart failure (nyha class iii and above) or left ventricular ejection fraction\<40% (ultrasonic or left ventricular angiography); 6. preoperative renal function: serum creatinine \> 2.0 mg/dl or 177 mu mol/l; receiving hemodialysis; 7. patients had ischemic stroke half a year before implantation, patients had transient ischemic attack 3 months before implantation, patients have high coagulation tendency judged by investigator or laboratory examination; 8. bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy; 9. aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies; 10. patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc; 11. the patient's life expectancy is less than 12 months; 12. patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame; 13. poor compliance and patients unable to complete the study in accordance with the requirements; 14. patient with heart transplant; 15. the unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia; 16. cancer needs chemotherapy; 17. patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy; 18. planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc; 19. with six months for elective surgery requires stop using aspirin and clopidogrel; 20. blood test prompted platelet count \ 700 x 10\^9/l, white blood cells \< 3 x 10\^9/l, or abnormal liver function (alt, ast 3 times greater than normal range); 21. patients with diffuse peripheral vascular disease; cannot use 6f catheter; 22. patients with valvular surgery in the past. exclusion criteria by angiography: 1. chronic total occlusion (timi blood flow=0 before implantation) , left main coronary artery lesion, ostial lesion, multiple vessel lesion, branch lesion and bridge lesion which branch vessel diameter ≥ 2.0 mm (if the ostium of branch vessel stenosis \>40% or needs balloon predilation); visible thrombus in target vessels; 2. severe calcified lesions and distorted disease which unable to predilation, lesion not suitable for stent delivery and expansion; 3. in-stent restenosis; 4. myocardial bridge is involved in target lesion; 5. in order to reach the target lesion, study stent has to go through the previous implanted stent; 6. predilation balloon can't expand completely in target lesion site, judgment standard for fully expansion as below, patients are excluded when do not meet any item: a.ds% \ 5 minutes), and f.no lower or higher st segment \>5 minutes. -