Clinical trial to evaluate efficacy and safety of KCS03 stent in a native coronary lesio
- Conditions
- Stable angina, unstable angina and non-ST elevated myocardial infarction with de novo or restenotic coronary lesions
- Registration Number
- JPRN-UMIN000010422
- Lead Sponsor
- Kaneka Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 115
Not provided
(1)Cardiogenic shock (2)After cardiopulmonary resuscitation (3)LVEF is less than 25% (4)Previous every DES implantation or scheduled DES implantation within 6 months against target vessel or side branches (5)Every PCI procedures within prior 30 days against coronary arteries (6)ST elevated myocardial infarction (7)Cerebral stroke or TIA within prior 30 days (8)Acute or chronic renal insufficiency (creatinine is more than 2.0mg/dL.) (9)Active gastric ulcer or active gastrointestinal bleeding (10)Life expectation is less than 12 months. (11)Non-target lesion requiring treatment is located in the target vessel or side branches of the target vessel. (12)Any lesions are located in LMT. (13)Target lesion is located in a bypass graft. (14)Target lesion is located in the ostium of the vessel. (15)Moderate or severe calcification is observed in target lesion or proximal side of target lesion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TVF at 6 months
- Secondary Outcome Measures
Name Time Method Technical success, procedural success, degree of stenosis immediately after the procedure, degree of stenosis (in-stent or in-segment) at 6 months, restenosis at 6 months, TLR at 6 months, TVR at 6 months, adverse events, stent thrombosis at 6 months, MACE at 6 months and length of hospital stay after the procedure