Comparison of the efficacy of new cutting balloon and scoring balloon for calcified lesions: Single-center, Randomized Controlled Trial: CASTELLA-CALC Trial

Comparison of the efficacy of new cutting balloon and scoring balloon for calcified lesions: Single-center, Randomized Controlled Trial: CASTELLA-CALC Trial - CASTELLA-CALC Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056400

Enrollment

160

Registered

2024-12-09

Start date

2024-12-01

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 Coronary Artery Disease

Interventions

Perform percutaneous coronary intervention (PCI) using a cutting balloon for coronary calcified lesions. Perform percutaneous coronary intervention (PCI) using a scoring balloon for coronary calcified

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ?Aged 20 years or older ?Patients with coronary calcified lesions undergoing percutaneous coronary intervention (PCI) ?Patients who have provided written informed consent, either personally or through a legal representative

Exclusion criteria

Exclusion criteria: ?Patients with a life expectancy of less than one year ?Acute coronary syndrome ?In-stent restenosis ?Chronic total occlusion lesions, left main coronary artery lesions, or bypass graft lesions ?Pregnant, planning to become pregnant, or breastfeeding female patients ?Other cases deemed unsuitable for inclusion by the principal investigator or co-investigators

Design outcomes

Primary

Measure	Time frame
Procedural Success Rate: Defined as the passage of the assigned investigational device through the lesion without additional devices, achieving residual angiographic stenosis of less than 30% under TIMI 3 flow.	—

Secondary

Measure	Time frame
1. Acute cross-sectional area (CSA) gain: Defined as post-interventional minimum lumen area minus pre-procedural minimum lumen area. 2. Calcium Fracture Thickness: Defined as the thickness of fractured calcium measured at the edges of the fracture, as assessed by OCT. 3. Incidence of Acute Complications: Defined as coronary dissection (Type C or higher) or perforation immediately following the use of the investigational device. 4. Major Cardiovascular Events Within 9 Months Post-PCI: Defined as a composite endpoint comprising cardiac death, recurrent myocardial infarction, rehospitalization due to unstable angina or progression of angina, clinically indicated target lesion revascularization, stroke, and major bleeding.	—

Measure

Time frame

1. Acute cross-sectional area (CSA) gain: Defined as post-interventional minimum lumen area minus pre-procedural minimum lumen area. 2. Calcium Fracture Thickness: Defined as the thickness of fractured calcium measured at the edges of the fracture, as assessed by OCT. 3. Incidence of Acute Complications: Defined as coronary dissection (Type C or higher) or perforation immediately following the use of the investigational device. 4. Major Cardiovascular Events Within 9 Months Post-PCI: Defined as a composite endpoint comprising cardiac death, recurrent myocardial infarction, rehospitalization due to unstable angina or progression of angina, clinically indicated target lesion revascularization, stroke, and major bleeding.

—

Countries

Japan

Contacts

Public ContactAkito Setoguchi

Nagasaki Harbor Medical Center Department of Cardiovascular Medicine

as.check.black@gmail.com095-822-3251

Outcome results

None listed

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