Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions
- Conditions
- Coronary Artery Disease
- Interventions
- Device: CRE8 sirolimus-eluting stent
- Registration Number
- NCT02360709
- Lead Sponsor
- CID S.p.A.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CRE8 group CRE8 sirolimus-eluting stent CRE8 sirolimus-eluting stent
- Primary Outcome Measures
Name Time Method Target lesion failure (TLF,device-oriented endpoint) 12months after the procedure
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fuwai Hospital,National Center for Cardiovasular disease
🇨🇳Beijing, Beijing, China