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

This is an interventional treatment trial for Coronary Artery Disease Read More

Inclusion Criteria:

Inclusion criteria for randomized cohort:

• 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.

Inclusion criteria for the long stent observational cohort:

• 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.

Exclusion Criteria:

• Patients with acute myocardial infarction (AMI) within one week;
• Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions;
• Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
• In-stent restenosis;
• Thrombotic lesion;
• Patients who had received any other stent in the past one year;
• Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
• Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months;
• Patients who allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, zotarolimus, polymer, Co-Cr alloy, or with contraindication to aspirin or clopidogrel or ticagrelor;
• Patients with life expectancy less than 1year;
• Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
• Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol;
• Patients who had underwent heart transplant surgery.