A multicenter, single-arm study to evaluate the safety and feasibility of PMA System for chronic total occlusion of coronary arteries

asu Kenya0 个研究点目标入组 20 人开始时间: 2023年5月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Submitted written consent to participate in the clinical trial of his/her own free will
•2. Eighteen years of age or older and under 80 years of age at the time of consent
•3. Has an eligible CTO
•4. CTO is not located at the coronary ostium
•5. The distal true lumen can be clearly visualized either by antegrade or contralateral injection
•6. Distal lumen diameter of CTO is 1.0 mm or more
•7. Has one of the following CTOs
•-One lesion (CTO) in one branch
•-Only 1 lesion can be treated with the investigational procedure if more than 2 CTOs
•8. Meets PCI eligibility criteria and allows CABG and coronary stenting
•9. Willing to undergo follow-up examinations and observations and able to visit the institution

•1. Heart rate not in 30 - 145 bpm range before PMA
•2. Permanent pacemaker implanted
•3. The target lesion of PMA is in the stent
•4. No more than 8 weeks after coronary stenting, regardless of target CTO branch
•5. LVEF < 30%
•6. Inability to take antiplatelet or anticoagulant therapy
•7. Allergic to iodinated contrast media
•8. Abnormal CK level or myocardial infarction in the past 72 hours
•9. Has lesions in the deep veins of the lower extremities
•10. Has a bleeding tendency or coagulopathy
•11. Impossible to perform emergency blood transfusion
•12. Serious gastrointestinal disease within 6 months before surgery
•13. Historoy of cerebrovascular disease (such as cerebral infarction or hemorrhage) within 3 months before surgery
•14. Pregnant, possibly pregnant or nursing
•15. Has severe dementia, drug addiction or alcoholism
•16. Has other serious illness
•17. Life expectancy <1 years
•18. Has participated in this clinical trial in the past
•19. Determined to be unsuitable by the principal investigator or subinvestigator

发起方

asu Kenya