EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-II)
|ClinicalTrials.gov Identifier: NCT02057978|
Recruitment Status : Enrolling by invitation
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases||Procedure: EXCEL DES implatation Procedure: EXCEL-II DES implantation||Phase 2|
The primary end point is to observe in-stent late lumenn loss after 9 months of the stent implantation.
This study is based on non-inferior assumption (vs. EXCEL-II V EXCEL Stent), requring all of end points reach statictic significance.
Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||416 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||5 Years|
|Official Title:||A Prospective Multicenter Randomized Trial to Assess the Safety and Effectiveness of EXCEL-II Sirolimus Eluting Stent vs. EXCEL Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery Lesions .( CREDIT II Trial )|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2019|
Use EXCEL DES implatationas as control group,Implant DES for CAD cases
Procedure: EXCEL DES implatation
Implant DES for CAD cases
Other Name: Implant DES for CAD cases
EXCEL-II DES implantation as control group,Implant DES for CAD cases
Procedure: EXCEL-II DES implantation
Implant DES for CAD cases
Other Name: Implant EXCEL-II DES for CAD cases
- 9 months in-stent late lumen loss [ Time Frame: 9 months ]To observe in-stent late lumen loss after 9 months of stent implantation
- 9-m in-segment diameter restenosis rate [ Time Frame: 9 months ]9-m in stent, proximal stent edge, the distal edge segment defined in the restenosis rate, 9-m after lesions within the segment late lumen loss percentage and the diameter of the restenosis degree
- Device success rates , lesion success rates , clinical success rates Device, lesion, & clinical success rates Device, lesion, & clinical success rates Target Lesion Failure [ Time Frame: 1m,6m,9m,12m,18m and annually to 5years ]Device oriented composite of cardiac death, MI, or ischemia-driven TLR at 1m, 6m, 12m,18m and annually up to 5 yrs
- Rate of stent thrombosis [ Time Frame: 1m,6m,9m,12m,18m and annually up to 5 yrs ]Definite and probable stent thrombosis according to ARC defination
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057978
|Shenyang Northern Hospital|
|Shenyang, Liaoning, China, 110015|
|Principal Investigator:||Han Yaling, PhD||Shenyang Northern Hospital|