Efficacy and Safety Evaluation of Biodegradable Peripheral Stent for Iliac Artery Lesions - KMP-001 Trial

KYOTO MEDICAL PLANNING Co., Ltd.0 个研究点目标入组 100 人开始时间: 2020年11月1日最近更新: 2023年10月17日

适应症

试验速览

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•1. Patient on dialysis or immunosuppressive therapy. 2. Patient with severe renal failure (serum creatinine > 2.0 mg/dL). 3. Patient who is allergic to drugs used for catheter treatment and examination (contrast agents, heparin, thienopyridine, aspirin, etc.). 4. Patient for whom antiplatelet and/or antithrombotic therapy is not available. 5. Patient on ongoing steroid hormone therapy. (ointments, creams due to skin diseases, eye drops, etc, and steroids during asthma attacks are allowed.) 6. Patient who requires debulking due to severe Calcification or other diseases. 7. Patient who has underwent stent implantation or surgical treatment within 10 mm distal / proximal from the target lesion. 8. Patient with in-stent restenosis. 9. Patient who developed myocardial infarction/cerebrovascular injury within 30 days before treatment. 10. Patient with acute or subacute obstruction at the target lesion. 11. Patient with hemorrhagic disease within the past 3 months. 12. Patient with aneurysms in abdominal aorta, iliac artery or other arteries. 13. (Possibly) pregnant women. 14. Patient who is not expected to live more than 12 months. 15. Patient who is enrolled in another clinical trial. In case that the patient has completed all the follow-ups in that study, he/she is eligible for this study. 16. Ineligible patient judged by PI (principal investigator) or other investigator .

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