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

Launched by CID S.P.A. · Feb 5, 2015

Keywords

ClinConnect Summary

This study consists of a randomized controlled cohort and a long stent observational cohort. The randomized controlled trial is a prospective, multi-center, non-inferior, randomized controlled trial. The control device (RESOLUTE zotarolimus-eluting stent) used in this trial was provided by Medtronic. RESOLUTE zotarolimus-eluting stent has been already approved by China Food and Drug Administration (CFDA) in 2009 and become commercially available in Chinese market. 400 patients enrolled in this trial will be randomly assigned to CRE8 group (n=200) and RESOLUTE group (n=200) in a 1:1 ratio. T...

Gender

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Eligibility criteria

• 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.