Coronary Stenosis
Conditions
Brief summary
The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.
Detailed description
30-day, 6-month, and 12-month clinical follow-up and 6 to 9-month IVUS or SCA follow-up to measure long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.
Interventions
DEVICEExcel Drug-eluting stent
Sponsors
JW Medical Systems Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who should fulfill with criteria of implanting Excel stents. * Each patient enrolled is only allowed to implant Excel stents. * Each patient are not allowed to be implanted more than 6 Excel stents.Also, 3 over-lapped stents are not allowed to be implanted in the same vessel(3-5mm overlapping needed; length of stents totally are not allowed to be over 80mm; fully post-dilated is essential for overlapping). * Patients acknowlegement to the trial is essential.
Exclusion criteria
* AMI withine 1 week. * Patients who do not suitable to Excel stenting.(For example, non-tolerant to anti-platelet drug or cardiac/non-cardiac surgery undergoing recently.) * Patients who have multiple branch lesions can not apply single Excel stenting. * Patients who refuse to sign the Trial Acknowledgement. * Patients with intra-stent restenosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month MACE | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day or 6-month MACE | — |
| 6 to 9-month restenosis rate by SCA follow-up | — |
Countries
China
Outcome results
None listed