JPRN-UMIN000010422
Completed
Phase 3
Clinical trial to evaluate efficacy and safety of KCS03 stent in a native coronary lesion - KCS03-1
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stable angina, unstable angina and non-ST elevated myocardial infarction with de novo or restenotic coronary lesions
- Sponsor
- Kaneka Corporation
- Enrollment
- 115
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(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.
Outcomes
Primary Outcomes
Not specified
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