The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.
This study consists of a randomized controlled cohort and a long stent observational cohort. The randomized controlled trial is a prospective, multi-center, non-inferior, randomized controlled trial. The control device (RESOLUTE zotarolimus-eluting stent) used in this trial was provided by Medtronic. RESOLUTE zotarolimus-eluting stent has been already approved by China Food and Drug Administration (CFDA) in 2009 and become commercially available in Chinese market. 400 patients enrolled in this trial will be randomly assigned to CRE8 group (n=200) and RESOLUTE group (n=200) in a 1:1 ratio. The long stent observational trial plans to enroll 30 consecutive patients. Patients in the observational cohort will receive the long CRE8 stent with length 38mm.All 430 patients will be required to receive clinical follow-up at 1 month, 6 months, 9 months, 12 months and annually up to 5 years after the procedure, and angiographic follow-up at 9 months after the procedure. The primary endpoint is in-stent LLL at 9 months after the procedure, and the secondary endpoints are device success rate, device-oriented cardiovascular composite endpoint, patient-oriented cardiovascular composite endpoint and stent thrombosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
The CRE8 stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium alloy and is coated with i-carbofilm.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.
The RESOLUTE stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium tungsten alloy. It has been approved by CFDA in 2009 and commercially available in Chinese market
Fuwai Hospital,National Center for Cardiovasular disease
Beijing, Beijing Municipality, China
RECRUITINGIn-stent late lumen loss (LLL)
Time frame: 9months after the procedure
In-stent, proximal stent edge, distal stent edge and In-segment binary restenosis rate
Time frame: 9months after the procedure
In-segment late lumen loss (LLL)
Time frame: 9months after the procedure
Target lesion failure (TLF) rate
Time frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
Number of participants with stent thrombosis per ARC definition
Time frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations
Time frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
device and lesion success rates
Time frame: immediately after the procedure
clinical success rate
Time frame: 7 days after the procedure
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