An observational study in Coronary Artery Disease, Myocardial Ischemia and Coronary Disease, sponsored by JW Medical Systems Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by JW Medical Systems Ltd · Observational
The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 419 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →JW Medical Systems Ltd is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will plan for a total of 416 patients with primary, in situ coronary artery lesions (all of the patients was selected in different blood vessels, a total of up to two target disease Variable and each target lesion 1 stents, such as placing stents need more than one in the operation, require the use of the same brand of stents, mix does not recommend the same patients Other brand support, unless save extra stents.) Choose lesions reference diameter of 2.5 mm to 2.5 mm (visual), each lesion length 32 mm or less (visual), participants must conform to the standard can be selected.
1.18yrs≤Age≤75yrs . 2.stability and unstable angina pectoris (AP), chronic myocardial infarction (OMI) or confirmed myocardial ischemia; 3.De novo lesion at native coronary artery(Up to two target lesions). 4.Lesion length ≤32mm. 5.RVD 2.5mm～4.0mm. 6.DS%≥70% by visual test. 7.Coronary artery bypass surgery (coronary artery bypass grafting) patients. 8.Subjects are willing to follow the specified requirements follow-up. 9.To understand the purpose of the trial and willing to sign informed consent and accept clinical follow-up.
Exclusion Criteria:
Use EXCEL DES implatationas as control group,Implant DES for CAD cases
Procedure: EXCEL DES implatation
EXCEL-II DES implantation as control group,Implant DES for CAD cases
Procedure: EXCEL-II DES implantation
Implant DES for CAD cases
Also known as: Implant DES for CAD cases
Implant DES for CAD cases
Also known as: Implant EXCEL-II DES for CAD cases
9 months in-stent late lumen loss
To observe in-stent late lumen loss after 9 months of stent implantation
Time frame: 9 months
9-m in-segment diameter restenosis rate
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
Time frame: 9 months
Device success rates , lesion success rates , clinical success rates Device, lesion, & clinical success rates Device, lesion, & clinical success rates Target Lesion Failure
Device oriented composite of cardiac death, MI, or ischemia-driven TLR at 1m, 6m, 12m,18m and annually up to 5 yrs
Time frame: 1m,6m,9m,12m,18m and annually to 5years
Rate of stent thrombosis
Definite and probable stent thrombosis according to ARC defination
Time frame: 1m,6m,9m,12m,18m and annually up to 5 yrs
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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JW Medical Systems Ltd