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

JRCT ID: jRCT2042230026

Registered date:26/05/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ischemic Heart Disease
• Date of first enrollment: 26/07/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Ablation with AI-RFGW-001 on a CTO lesion

Outcome(s)

• Primary Outcome: Penetration 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Nasu Kenya