UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057880 |
|---|---|
| Receipt number | R000065988 |
| Scientific Title | A multicenter prospective observational study comparing the efficacy of pre-dilation with a scoring balloon after intravascular lithotripsy in severely calcified lesions using optical coherence tomography. |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/07 21:49:01 |
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Basic information
Public title
A study to confirm the efficacy of a blade balloon followed by sonic-wave crack-and-treat therapy to calcified plaque in coronary arteries.
Acronym
SPLIT-IVL
Scientific Title
A multicenter prospective observational study comparing the efficacy of pre-dilation with a scoring balloon after intravascular lithotripsy in severely calcified lesions using optical coherence tomography.
Scientific Title:Acronym
SPLIT-IVL
Region
| Japan |
Condition
Condition
Coronary artery disease with severe calcification
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to evaluate whether intravascular lithotripsy (IVL) for calcified lesions and dilatation with a scoring balloon before stent placement results in superior optical coherence tomography findings compared to stent placement after dilatation with a non-compliant balloon or without pre-dilatation. For this reason, we will prospectively register patients who use IVL at our hospital and other hospitals, build evidence of coronary revascularization using IVL in Japan, and link it to future new prospective intervention studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Minimal stent area and stent expansion index between 3 groups by OCT analysis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Ueda |
Organization
Nara Medical University
Division name
Department of Cardiovascular Medicine
Zip code
634-0813
Address
840, Shijo, Kashihara city, Nara
TEL
0744-22-3051
tom15@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kyodo |
Organization
Nara Medical University
Division name
Department of Cardiovascular Medicine
Zip code
634-0813
Address
840, Shijo, Kashihara city, Nara
TEL
0744-22-3051
Homepage URL
kyon1054@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840, Shijo, Kashihara city, Nara
Tel
0744-22-3051
ino_rinri@naramed-u.ac.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
奈良県立医科大学附属病院(奈良県)、奈良県総合医療センター（奈良県）、奈良県西和医療センター（奈良県）、市立奈良病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 30 | 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
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
Prospective cohort study
Study Population
Patients who meet the inclusion criteria at the participating centers between 1 May 2025 and 31 March 2027.
Endpoints
Primary endpoints
1.Minimal Stent Area
2.Stent Expansion Index
Secondary endpoints
1. Number of cracks on OCT/OFDI immediately before stent implantation after IVL
2. Minimal Lumen Area on OCT/OFDI immediately before stent implantation after IVL
3. Target lesion revascularization rate at the target site 1 year after PCI
4. Minimal Lumen Area of the target lesion on OCT/OFDI at the 1 year follow up
Management information
Registered date
| 2025 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065988
