Coronary Artery Stenosis
Conditions
Keywords
Stents Coronary Artery Disease
Brief summary
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world. Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System
Detailed description
The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System. The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes \>= 2.5 mm and \<= 4 mm. All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT. All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .
Interventions
DEVICECordimax
One rapamycin eluting stent for treating the adapted coronary patients
DEVICEXIENCE V
One everolimus eluting stent for treating the adapted coronary patients
Sponsors
Fudan University
Shandong Branden Med.Device Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age 18 years old or more 2. patients with symptomatic coronary artery disease 3. adapt to the DES treatment according to guide 4. with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5\ 4.0 mm) in diameter ;has the objective basis of myocardial ischemia 5. patients willing to participate and sign in research
Exclusion criteria
1. Women in pregnancy or lactation 2. Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation 3. Patients were banned to use the antiplatelet and/or anticoagulant therapy 4. Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project 5. Patients who must stop clopidogrel to accept a elective surgery 6. patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure(TLF) | at 1st year | including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombotic events incidence | at30 60 90 days and 1st 2st 3st 4st 5st year | According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d |
| Major adverse cardiovascular events (MACE) | at30 60 90 days and 1st 2st 3st 4st 5st year | Events include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven |
| The Success Rate of Stent Placement | in the operation | The stent can arrive and through the target lesion area, and can be expanded finally. |
| Operation Success Rate | 0 to 24 hours after intervention | After stent implantation, stent diameter stenosis \< 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen. |
| Cost of the hospitalization | 0 to 24hours after discharge | The total expenses in the process of operation |
| Length of stay | 0 to 24 hours after discharge | The total time consumption in the process of operation |
Countries
China
Outcome results
None listed