Clinical Study to Evaluate the Performance and Safety of AI-OR-001

JRCT ID: jRCTs022210064

Registered date:14/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ischemic Heart Disease
• Date of first enrollment: 16/03/2022
• Target sample size: 2
• Study type: Interventional
• Intervention(s): Using an unapproved medical device

Outcome(s)

• Primary Outcome: Device Success (guiding the antegrade and retrograde guidewires into the same space and guiding the retrograde guidewire into the antegrade guiding catheter)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Target lesion: Coronary Chronic Total Occlusion (CTO) with a target vessel diameter of 1.0 to 4.0 mm, to which a retrograde approach is applicable
2.Ages: 20 years and older
3.Sexes: All
4.Willing and able to provide written informed consent

Exclude criteria

1.Retrograde approach is not applicable for CTO-PCI
2.Undergo PCI for Acute Coronary Syndrome
3.Inability to take antiplatelet medications
4.Pregnant, have childbearing potential, within 28 days after childbirth or lactating
5.With a history of serious allergic reactions to contrast materials or other drugs required for the procedure
6.With a history of coronary artery spasm
7.Coronary artery bypass grafting is not applicable
8.May have difficulty in participating in this study due to psychiatric disorder

Related Information

• Primary Sponsor: Nasu Kenya
• Source(s) of Monetary Support: Asahi Intecc Co., Ltd.