Coronary artery disease with severe calcification
Conditions
Interventions
None listed
Sponsors
Nara Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 or more and under 100 years. 2. Patients scheduled to undergo PCI with VL in the target vessel. 3. Patients whose target lesion can be evaluated by OCT/OFDI prior to IVL, with an OCT/OFDI calcification score 3 or more, and who undergo IVL in the target vessel. Balloon dilation after IVL is permitted but not required. 4. Patients (or their legally authorized representatives) who provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients with comorbidities that limit their expected survival to less than one year. 2. Patients for whom IVL is deemed inappropriate based on the OCT/OFDI calcification score. 3. Patients who do not undergo IVL. 4. Patients whose intravascular imaging prior to IVL cannot be evaluated. 5. Patients in whom stent implantation cannot be performed after IVL. 6. Patients currently enrolled in another clinical trial of catheter-based treatment for a different coronary artery. 7. Patients for whom circumstances are judged to compromise patient safety or adherence to the study protocol. 8. Patients deemed unsuitable by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Minimal stent area and stent expansion index between 3 groups by OCT analysis | — |
Countries
Japan
Contacts
Public ContactAtsushi Kyodo
Nara Medical University Department of Cardiovascular Medicine
Outcome results
None listed