Safety and Efficacy of the CRE8 Stent for the Treatment of De Novo Coronary Artery Lesions

Inclusion Criteria

• •Age ≥18 years and ≤ 75 years, male or female without pregnancy;
• •Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
• •De novo lesions of native coronary arteries (lesions number ≤ 2);
• •Target vessel diameter between 2.25 and 4.0 mm and target lesion length ≤ 27mm by visual estimation;
• •Target lesion diameter stenosis ≥ 70% by visual estimation;
• •Each target lesion is permitted to implant only one stent at most, except bailout stent;
• •Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
• •Patients with left ventricular ejection fraction ≥40%;
• •Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consent.
• •Age ≥18 years and ≤ 75 years, male or female without pregnancy;
• •Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
• •De novo lesions of native coronary arteries (lesions number ≤ 2);
• •Target lesion diameter stenosis ≥ 70% by visual estimation;
• •At least one target lesion with reference vessel diameter between 2.5mm and 4.0mm and requires 38mm stent exists;
• •Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
• •Patients with left ventricular ejection fraction ≥40%;
• •Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consent.