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Evaluating the usability and safety of 4Fr straight shaped guiding catheter `KIWAMI` (Terumo Corporation) by using mother-and-child technique with severe lesions.

Evaluating the usability and safety of 4Fr straight shaped guiding catheter `KIWAMI` (Terumo Corporation) by using mother-and-child technique with severe lesions. - Evaluation of PCI devices' delivery success rate by using KIWAMI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000002679
Enrollment
30
Registered
2009-10-27
Start date
2009-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic heart disease (IHD)

Interventions

None listed

Sponsors

Kyusyu KIWAMI regstry group
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Delivery success rate of PCI devices to the target lesion.

Secondary

MeasureTime 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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026