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

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

11

Age: 65.9 +/- 8.2 years Height: 162.65 +/- 7.46 cm Weight: 66.70 +/- 8.39 kg Gender: 8 males (72.7%), 3 females (27.3%)

Treatment with the investigational device was administered to 11 participants, and all 11 (100%) completed the study. No participants were excluded from the analysis population.

Of the 11 participants, 8 adverse events occurred in 4 participants (36.4%). -Coronary perforation: 3 (27.3%) -Myocardial infarction: 2 (18.2%) -Cardiac tamponade: 1 (9.1%) -Chest pain: 1 (9.1%) -Hemorrhagic stroke: 1 (9.1%) Of these, 2 adverse events were causally related to the investigational device in 2 participants (18.2%). None of the adverse events were serious adverse events. -Coronary perforation: 1 (9.1%) -Chest pain: 1 (9.1%) Two serious adverse events occurred in one participants (9.1%). Both were judged not to be causally related to the investigational device. -Coronary perforation -Cardiac tamponade

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: success with 11 participants (100%, 95%CI 71.5 - 100.0)

The primary objective of this clinical trial, "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," was successful in 11 of 11 participants (100%), thus confirming the feasibility of this investigational product.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2042230026

Nasu Kenya

Mie Heart Center

2227-1, Oyodo, Taki Gun Meiwa Cho, Mie Ken

kestymaro1121@gmail.com

Clinical Affairs Office

ASAHI INTECC CO., LTD.

3-100, Akatsukicho, Seto Shi, Aichi Ken

+81-561-41-8330

chiken@asahi-intecc.com

Complete

June. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

Ischemic Heart Disease

Ablation with AI-RFGW-001 on a CTO lesion

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

+81-596-55-8188

May. 23, 2023

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