AMI
Conditions
Brief summary
The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of coronary heart disease and inhibition of restenosis after coronary artery stenting as well as a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs used for 6 months after the implantation of degradable drug coating stent.
Interventions
DEVICEExcel drug-eluting coronary artery stent
Sponsors
JW Medical Systems Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patient who should be full fill the criteria of using Excel stent. 2. Each included patient should allowed to use Excel stent. 3. Complete revascularization can be achieved through one invasive operation.
Exclusion criteria
1. Patient do not suitable to use Excel stent, for example, not tolerant to anti-platelet drug or undergo cardiac/non-cardiac surgery recently. 2. Patient with multiple branch lesions, thus the single Excel stent cannot resolve the condition. 3. NYH Cardiac functional grading\>3 or Echocardiography LVEF\<0.3. 4. Patient with complete revascularization cannot be resolved by one operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE(Major adverse cardiac events) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| MACE | 30 days and 6 months |
Outcome results
None listed