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.
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.
Study Type
OBSERVATIONAL
Enrollment
800
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.
Fuwai Hospital,National Center for Cardiovasular disease
Beijing, Beijing Municipality, China
RECRUITINGTarget lesion failure (TLF,device-oriented endpoint)
Time frame: 12months after the procedure
Target lesion failure (TLF,device-oriented endpoint)
Time frame: 1month,6months,2years,3years,4years and 5years follow-up
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations
Time frame: 1month,6months,12months and annually up to 5years follow-up
Stent thrombosis per ARC definition
Time frame: 1month,6months,12months and annually up to 5years follow-up
device and lesion success rates
Time frame: immidiately after the procedure
clinical success rate
Time frame: 7 days after the procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.