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

CID S.p.A.

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Device: CRE8 sirolimus-eluting stent

Study type

Observational

Funder types

Industry

Identifiers

NCT02360709

CRE8-China-SA

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.