Ignite Creation Date:
2024-05-06 @ 2:20 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02027870
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2014-01-02
Brief Title:
EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions CREDIT-III
Sponsor:
Organization:
JW Medical Systems Ltd
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
True
Target Duration:
5 Years
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
NONE_RETAINED
Bio Spec Description:
According to the CREATE Multi - Center Registry of Excel Biodegradable Polymer Drug Eluting Stent registration results show that ExcelTM drug-eluting stents implanted an average of 12 months target lesion TLF the failure rate of 67Will this study expected target lesion group stent failure rate estimate of 67 the target is 95Test hypothesis bilateral 005 005 master degree clinical follow-up requirements is more than 95 this research need at least 829 patients remove the CREDIT II randomized controlled study can provide the number of cases of test group 208 examples this study still need to be included in the 621 patients
Enrollment Count:
625
Enrollment Type:
ACTUAL
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Case-Only |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 23939 |
Who Masked List: