NIPH Clinical Trials Search

JRCT ID: jRCT2042230026

Registered date:26/05/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedIschemic Heart Disease
Date of first enrollment26/07/2023
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Ablation with AI-RFGW-001 on a CTO lesion


Primary OutcomePenetration of this investigational product's guidewire or conventional guidewire into the distal true lumen of the CTO lesion by the intended use of the investigational product
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum< 80age old
Include criteria1. 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
Exclude criteria1. 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

Related Information


Public contact
Name Clinical Affairs Office
Address 3-100, Akatsukicho, Seto Shi, Aichi Ken Aichi Japan 489-0071
Telephone +81-561-41-8330
Affiliation ASAHI INTECC CO., LTD.
Scientific contact
Name Kenya Nasu
Address 2227-1, Oyodo, Taki Gun Meiwa Cho, Mie Ken Mie Japan 515-0302
Telephone +81-596-55-8188
Affiliation Mie Heart Center