Ischemic heart disease (IHD)
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with ischemic heart disease with all of the following criteria will be eligible for enrollment: 1. Are age > 20 years. 2. Have angiographic findings of ischemic heart disease and are eligible to receiving elective PCI treatment. 3. Have consented to participate and have signed the patient informed consent form which is approved by IRB to submit to the implementing institute. 4. Are applicable to coronary artery bypass grafting (CABG).
Exclusion criteria
Exclusion criteria: 1.Exhibit angiographic evidence of severe thrombus in the target site and determined by the physician that the enrollment is not eligible. 2.Have symptoms of unstable angina pectoris and determined by the physician that the enrollment is not eligible. 3.Have symptoms of myocardial infarction and determined by the physician that the enrollment is in not eligible. 4.Have a contraindication to antiplatelet or anticoagulation therapy. 5.Have allergies to contrast media, metal, or other medical agents / materials. 6.Have small reference vessel diameter at the lesion which is suspected as inducing ischemic heart disease by using KIWAMI. 7.Others: Any cases when the physician determined that the enrollment is not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delivery success rate of PCI devices to the target lesion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The incidence of ST elevated myocardial infarction in case of successful delivery of PCI devices. 2. The incidence of non-ST elevated myocardial infarction after successful deliver of PCI devices. 3. ST changes after successful deliver of PCI devices. 4. Changes at subjective and objective symptoms. 5. Presence of adverse events | — |
Countries
Japan