UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052332 |
|---|---|
| Receipt number | R000059744 |
| Scientific Title | Optimal Protocol of Intravascular Imaging-Guided Intravascular Lithotripsy for Calcified Coronary Lesions |
| Date of disclosure of the study information | 2023/09/28 |
| Last modified on | 2024/06/16 18:09:48 |
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Basic information
Public title
Optimal Protocol of Intravascular Imaging-Guided Intravascular Lithotripsy for Calcified Coronary Lesions
Acronym
OPTIVL Study
Scientific Title
Optimal Protocol of Intravascular Imaging-Guided Intravascular Lithotripsy for Calcified Coronary Lesions
Scientific Title:Acronym
OPTIVL Study
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to assess the safety and efficacy of the prespecified protocol for determining the IVL balloon size based on intravascular imaging findings (IVUS or OCT). The IVL balloon size is decided according to the calcification pattern (i.e., circumferential or eccentric pattern). In cases of the circumferential pattern, IVL balloon size is defined as "larger distal reference lumen diameter (LDRLD) or LDRLD+0.25 mm". In cases of the eccentric pattern, "larger distal reference lumen diameter (LDRLD)-0.25 or 0.50 mm. When intravascular imaging after IVL shows >=2 cracks, drug-eluting stent implantation is recommended as the next step. If not, additional dilatation with a cutting balloon is recommended.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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)
Key secondary outcomes
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)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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)
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Sapporo Cardio Vascular Clinic
Division name
Cardiovascular Medicine
Zip code
007-0849
Address
North 49, East 16, 8-1, Higashi Ward, Sapporo, Japan
TEL
0117847847
kuramitsu@heart-kizuna.com
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Sapporo Cardio Vascular Clinic
Division name
Cardiovascular Medicine
Zip code
007-0849
Address
North 49, East 16-1, Higashi Ward, Sapporo, Japan
TEL
0117847847
Homepage URL
kuramitsu@heart-kizuna.com
Sponsor or person
Institute
Sapporo Cardio Vascular Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Cardio Vascular Clinic
Address
North 49, East 16-1, Higashi Ward, Sapporo, Japan
Tel
0117847847
kuramitsu@heart-kizuna.com
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
| 2023 | Year | 09 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059744
