Coronary Artery Disease
Conditions
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.
Interventions
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.
Sponsors
CID S.p.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF,device-oriented endpoint) | 12months after the procedure |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactShubin Qiao, MD
Outcome results
None listed