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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXCEL DES | Use EXCEL DES implatationas as control group,Implant DES for CAD cases |
| |
| EXCEL-II DES | EXCEL-II DES implantation as control group,Implant DES for CAD cases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXCEL DES implatation | Procedure | Implant DES for CAD cases |
|
| Measure | Description | Time Frame |
|---|---|---|
| 9 months in-stent late lumen loss | To observe in-stent late lumen loss after 9 months of stent implantation | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 months |
| Device success rates , lesion success rates , clinical success rates Device, lesion, & clinical success rates Device, lesion, & clinical success rates Target Lesion Failure |
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Inclusion criteria:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Han Yaling, PhD | Shenyang Northern Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenyang Northern Hospital | Shenyang | Liaoning | 110015 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29493880 | Derived | Xu K, Han Y, Xu B, Yang Y, Wang G, Li H, Sun Y, Tao L, Wang H, Yuan Z, Liu H, Liu J, Jia Y, Ma G, Fu G, Li X, Li S, Wang S, Pu K; CREDIT 2 Investigators. Efficacy and safety of a second-generation biodegradable polymer sirolimus-eluting stent: One-year results of the CREDIT 2 trial. Cardiovasc Ther. 2018 Jun;36(3):e12327. doi: 10.1111/1755-5922.12327. Epub 2018 Mar 25. |
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Endpoint Classification: Safety/Efficacy Study Enrollment: 416 cases [Anticipated]
| EXCEL-II DES implantation | Procedure | Implant DES for CAD cases |
|
|
Device oriented composite of cardiac death, MI, or ischemia-driven TLR at 1m, 6m, 12m,18m and annually up to 5 yrs |
| 1m,6m,9m,12m,18m and annually to 5years |
| Rate of stent thrombosis | Definite and probable stent thrombosis according to ARC defination | 1m,6m,9m,12m,18m and annually up to 5 yrs |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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