UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055354 |
|---|---|
| Receipt number | R000063246 |
| Scientific Title | Pathological analysis of atherosclerotic human blood vessels after usage of Shockwave intravascular lithotripsy device |
| Date of disclosure of the study information | 2024/08/28 |
| Last modified on | 2024/08/28 10:04:30 |
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Basic information
Public title
Pathological analysis of atherosclerotic human blood vessels after usage of Shockwave intravascular lithotripsy device
Acronym
Pathological analysis of atherosclerotic human blood vessels after usage of Shockwave intravascular lithotripsy device
Scientific Title
Pathological analysis of atherosclerotic human blood vessels after usage of Shockwave intravascular lithotripsy device
Scientific Title:Acronym
Pathological analysis of atherosclerotic human blood vessels after usage of Shockwave intravascular lithotripsy device
Region
| Japan |
Condition
Condition
Coronary Artery Disease and Peripheral Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to apply Shockwave intravascular lithotripsy (IVL) to severely calcified arteriosclerotic blood vessels (e.g., cardiac coronary arteries, lower extremity arteries) that were resected from the body for certain reasons, and observe the changes pathologically and by various imaging modalities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calcium fractures identified by various imaging devices and histological images after IVL to assess the efficacy of IVL in highly calcified lesions
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ischemic heart disease or lower limb arterial disease who have undergone surgery or autopsy to remove their arteries.
Patients who have given their or their families consent to participate in this study.
Key exclusion criteria
Patients without provision of consent under either of the following circumstances (i) and (ii):
(i) Patients without consent of their own or family members
(ii) Other patients judged to be ineligible by the investigator/sub-investigator
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Torii |
Organization
Tokai University School of Medicine
Division name
Department of Cardiology
Zip code
2591193
Address
143, Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
shoz3333@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Torii |
Organization
Tokai University School of Medicine
Division name
Division of Cardiology
Zip code
2591193
Address
143, Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
shoz3333@gmail.com
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Sho Torii
Funding Source
Organization
Shockwave Medical, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokai University School of Medicine
Address
143, Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rec@tokai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pathological study
Management information
Registered date
| 2024 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063246
