Ischemic Heart Disease
Conditions
Interventions
Using an unapproved medical device
Sponsors
Nasu Kenya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device Success (guiding the antegrade and retrograde guidewires into the same space and guiding the retrograde guidewire into the antegrade guiding catheter) | — |
Contacts
Public ContactKenya Nasu
Toyohashi Heart Center
Outcome results
None listed