UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056400 |
|---|---|
| Receipt number | R000064274 |
| Scientific Title | Comparison of the efficacy of new cutting balloon and scoring balloon for calcified lesions: Single-center, Randomized Controlled Trial: CASTELLA-CALC Trial |
| Date of disclosure of the study information | 2024/12/09 |
| Last modified on | 2025/12/07 12:16:52 |
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Basic information
Public title
Comparison of the efficacy of new cutting balloon and scoring balloon for calcified lesions: Single-center, Randomized Controlled Trial: CASTELLA-CALC Trial
Acronym
CASTELLA-CALC Trial
Scientific Title
Comparison of the efficacy of new cutting balloon and scoring balloon for calcified lesions: Single-center, Randomized Controlled Trial: CASTELLA-CALC Trial
Scientific Title:Acronym
CASTELLA-CALC Trial
Region
| Japan |
Condition
Condition
Ischemic Heart Disease
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Collect clinical case data where drug-eluting stents (DES) or drug-coated balloons (DCB) were used after pre-dilation with KIZASHI or Aperta NSE, and evaluate their patency, expansion efficacy, and medium- to long-term outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform percutaneous coronary intervention (PCI) using a cutting balloon for coronary calcified lesions.
Interventions/Control_2
Perform percutaneous coronary intervention (PCI) using a scoring balloon for coronary calcified lesions.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Takeno |
Organization
Nagasaki Harbor Medical Center
Division name
Department of Cardiovascular Medicine
Zip code
850-0842
Address
6-39 Shinchi-machi, Nagasaki City, Nagasaki Prefecture, Japan
TEL
095-822-3251
takeno_masayoshi@ncho.jp
Public contact
Name of contact person
| 1st name | Akito |
| Middle name | |
| Last name | Setoguchi |
Organization
Nagasaki Harbor Medical Center
Division name
Department of Cardiovascular Medicine
Zip code
850-0842
Address
6-39 Shinchi-machi, Nagasaki City, Nagasaki Prefecture, Japan
TEL
095-822-3251
Homepage URL
as.check.black@gmail.com
Sponsor or person
Institute
Nagasaki Harbor Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research and Development Center
Address
6-39 Shinchi-machi, Nagasaki City, Nagasaki Prefecture, Japan
Tel
095-822-3251
kenkyu@ncho.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064274
