A First-in-Man Study 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:

• Target lesion failure (TLF) at 6 months post procedure
• Late Lumen Loss at 6 months post procedure

Inclusion criteria

All patients participating in this clinical trial must meet the following criteria:

• Age of 18-75, males or non pregnancy females;
• Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI;
• One target lesion, and target lesion can be completely covered by a single stent;
• Target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual);
• Visual assessment of target lesion stenosis ≥70%, TIMI blood flow≥ 1;
• 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:

• 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;
• Patients who had coronary artery bypass (coronary artery bypass grafting);
• Patients with contraindications for coronary artery bypass graft surgery;
• Severe heart failure (NYHA class III and above) or left ventricular ejection fraction<40% (ultrasonic or left ventricular angiography);
• Preoperative renal function: serum creatinine > 2.0 mg/dl or 177 mu mol/L; receiving hemodialysis;
• 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;
• Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy;
• Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies;
• Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc;
• The patient's life expectancy is less than 12 months;
• Patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame;
• Poor compliance and patients unable to complete the study in accordance with the requirements;
• Patient with heart transplant;
• The unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia;
• Cancer needs chemotherapy;
• Patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy;
• Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
• With six months for elective surgery requires stop using aspirin and clopidogrel;
• Blood test prompted platelet count < 100 x 10^9/L, or > 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);
• Patients with diffuse peripheral vascular disease; cannot use 6F catheter;
• Patients with valvular surgery in the past.

Exclusion criteria

by angiography:

• 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;
• Severe calcified lesions and distorted disease which unable to predilation, lesion not suitable for stent delivery and expansion;
• In-stent restenosis;
• Myocardial bridge is involved in target lesion;
• In order to reach the target lesion, study stent has to go through the previous implanted stent;
• 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% < 40% (visual), highly recommend DS% ≤20% B.TIMI blood flow= class 3 (visual) C.No angiography complications (e.g., distal embolization, lateral branch closed) D.No interlining level NHLBI type D - F E.No continuous chest pain (> 5 minutes), and F.No lower or higher ST segment >5 minutes.

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