- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02057978
EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-II)
A Prospective Multicenter Randomized Trial to Assess the Safety and Effectiveness of EXCEL-II vs. EXCEL Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery Lesions .( CREDIT II Trial )
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110015
- Shenyang Northern Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- AMI within 7 days.
- CTO (TIMI 0), the left main lesion, ostial lesion and transplant vascular lesions, the bifurcation lesion (reference collateral blood vessel diameter of 2.5 mm or higher), stent restenosis lesions and to deal with three pathological changes;
- Severe calcified lesion unable to predilate.
- The distortion of the stent was hampered by lesions.
- NYHA≥Ⅲ or LVEF<40%.
- Prior PCI within 1 year.
- Pregnancy or lactation, and planning pregnancy or lactation.
- Subjects have bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue to take DAPT at least 1 year.
- There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
- To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
- Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
- Before enrolling to participate in other clinical trials and not reached the primary endpoint.
- Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
EXCEL DES
Use EXCEL DES implatationas as control group,Implant DES for CAD cases
|
Implant DES for CAD cases
Other Names:
|
EXCEL-II DES
EXCEL-II DES implantation as control group,Implant DES for CAD cases
|
Implant DES for CAD cases
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
9 months
|
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
|
1m,6m,9m,12m,18m and annually to 5years
|
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
|
1m,6m,9m,12m,18m and annually up to 5 yrs
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Han Yaling, PhD, Shenyang Northern Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Cardiovascular Diseases
- Vascular Diseases
- Ischemia
- Arterial Occlusive Diseases
- Arteriosclerosis
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Dermatologic Agents
- Disinfectants
- Chlorhexidine
- Chlorhexidine gluconate
Other Study ID Numbers
- CREDIT-II-131105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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