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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.

Detailed Description
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This is a prospective, multi-center, single-arm observational registry trial planned to enroll 800 subjects. All 800 subjects enrolled will receive CRE8 stents. Clinical follow-up will be performed at 1 month, 6 months,12 months and annually up to 5 years after the procedure.

Official Title
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A Prospective, Multi-center, Single-arm Observational Registry Trial Evaluating the Safety and Efficacy of CRE8 Sirolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: CRE8 sirolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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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; Target vessel diameter between 2.25mm and 4.5 mm, and target lesion length ≤ 60mm by visual estimation; Target lesion diameter stenosis ≥ 70% by visual estimation; Each target lesion must be implanted the same stent (CRE8); 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 consents. Exclusion Criteria: Patients with acute myocardial infarction (AMI) within 72 hours; Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment; 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 lesions; 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, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRE8 group<br>CRE8 sirolimus-eluting stent | Device: CRE8 sirolimus-eluting stent<br>* The CRE8 stent system consists of a sirolimus eluting coronary stent firmly held on the distal end of a semicompliant balloon catheter. This stent is made of cobalt chromium alloy and is coated with a thin carbon film.The outer surface of the stent has dedicated grooves for containing the pharmaceutical formulation, which is composed of the drug sirolimus and a mixture of long chain fatty acids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure (TLF,device-oriented endpoint) |  | 12months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure (TLF,device-oriented endpoint) |  | 1month,6months,2years,3years,4years and 5years follow-up | 
| The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations |  | 1month,6months,12months and annually up to 5years follow-up | 
| Stent thrombosis per ARC definition |  | 1month,6months,12months and annually up to 5years follow-up | 
| device and lesion success rates |  | immidiately after the procedure | 
| clinical success rate |  | 7 days after the procedure |