Optimal Protocol of Intravascular Imaging-Guided Intravascular Lithotripsy for Calcified Coronary Lesions

Optimal Protocol of Intravascular Imaging-Guided Intravascular Lithotripsy for Calcified Coronary Lesions - OPTIVL Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052332

Enrollment

100

Registered

2023-09-28

Start date

2023-10-01

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

Coronary Artery Disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients willing to provide written informed consent 2) Patients over 20 years old 3) Patients in whom PCI is clinically indicated 4) Patients who meet the criteria for IVL (OCT calcium score >=3)

Exclusion criteria

Exclusion criteria: 1) Culprit lesions in patients with acute coronary syndrome 2) Graft lesions 3) In-stent restenosis lesions 4) Patients with congestive heart failure 5) Patients deemed inappropriate for inclusion by the principal investigators

Design outcomes

Primary

Measure	Time frame
1) The success rate of making any calcium cracks (>=1) after IVL without any IVL-related complications (primary effectiveness endpoint) 2) 30-day outcomes (cardiac death, target vessel-related myocardial infarction, stent thrombosis, target vessel revascularization)(primary safety endpoint)	—

Secondary

Measure	Time frame
1) The success rate of making any calcium cracks (>=1) before stent implantation 2) Comparing the intravascular imaging findings before and after cutting balloon dilatation followed by IVL 3) Incidence rate of IVL-related complications (eg. major dissection and coronary perforation) 4) Factors associated with calcium fracture after IVL (comparison between IVUS and OCT) 5) Frequency of discordant results between OCT- and IVUS-based Ca scoring systems 6) The success rate of achieving the optimal stent expansion (SEI >=90%) 7) Factors associated with suboptimal stent expansion (SEI <90%) 8) The procedural success rate (residual stenosis <50% without any in-hospital events) 9) 1-year outcomes (cardiac death, target vessel-related myocardial infarction, stent thrombosis, target vessel revascularization)	—

Measure

Time frame

1) The success rate of making any calcium cracks (>=1) before stent implantation 2) Comparing the intravascular imaging findings before and after cutting balloon dilatation followed by IVL 3) Incidence rate of IVL-related complications (eg. major dissection and coronary perforation) 4) Factors associated with calcium fracture after IVL (comparison between IVUS and OCT) 5) Frequency of discordant results between OCT- and IVUS-based Ca scoring systems 6) The success rate of achieving the optimal stent expansion (SEI >=90%) 7) Factors associated with suboptimal stent expansion (SEI <90%) 8) The procedural success rate (residual stenosis <50% without any in-hospital events) 9) 1-year outcomes (cardiac death, target vessel-related myocardial infarction, stent thrombosis, target vessel revascularization)

—

Countries

Japan

Contacts

Public ContactShoichi Kuramitsu

Sapporo Cardio Vascular Clinic Cardiovascular Medicine

kuramitsu@heart-kizuna.com0117847847

Outcome results