Coronary Artery Disease Clinical Trial
— CREDIT-IIOfficial title:
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 )
Verified date | April 2023 |
Source | JW Medical Systems Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 419 |
Est. completion date | December 25, 2019 |
Est. primary completion date | October 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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: 1. AMI within 7 days. 2. 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; 3. Severe calcified lesion unable to predilate. 4. The distortion of the stent was hampered by lesions. 5. NYHA=? or LVEF<40%. 6. Prior PCI within 1 year. 7. Pregnancy or lactation, and planning pregnancy or lactation. 8. 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. 9. 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). 10. To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy. 11. Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal). 12. Before enrolling to participate in other clinical trials and not reached the primary endpoint. 13. Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects. |
Country | Name | City | State |
---|---|---|---|
China | Shenyang Northern Hospital | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
JW Medical Systems Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 9 months in-stent late lumen loss | To observe in-stent late lumen loss after 9 months of stent implantation | 9 months | |
Secondary | 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 | |
Secondary | 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 | 1m,6m,9m,12m,18m and annually to 5years | |
Secondary | Rate of stent thrombosis | Definite and probable stent thrombosis according to ARC defination | 1m,6m,9m,12m,18m and annually up to 5 yrs |
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