UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047172 |
|---|---|
| Receipt number | R000052805 |
| Scientific Title | Certification of vasa vasorum of No touch vein graft |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2024/03/24 19:10:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Certification of vasa vasorum of No touch vein graft
Acronym
Certification of vasa vasorum of No touch vein graft
Scientific Title
Certification of vasa vasorum of No touch vein graft
Scientific Title:Acronym
Certification of vasa vasorum of No touch vein graft
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to the research morphology between the no-touch" vein graft and conventional one using OCT.
Basic objectives2
Others
Basic objectives -Others
Comparing the graft patency between the no-touch" vein graft and a conventional one at the time of CAG post CABG.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Patency of vasa vasorum, Diameter of the graft, Volume of adventisial tissue
Key secondary outcomes
Graft patency of vein graft after one week from CABG.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Optical interferometry on the conventional great saphenous vein to bypass graft
Interventions/Control_2
Optical interferometry on the no touch great saphenous vein to bypass graft
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients undergoing routine CABG were harvested with their surrounding tissue using the no-touch SVG harvesting technique.
Key exclusion criteria
Under 20 years old. Cases deemed ineligible by the attending doctor.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | AKIRA |
| Middle name | |
| Last name | SUGAYA |
Organization
Jichi Medical University, School of Medicine
Division name
Department of Cardiovascular Surgery,
Zip code
329-0498
Address
Yakushiji 3311-1, Shimotsuke, Tochigi
TEL
+81-285-58-7368
sugaya@jichi.ac.jp
Public contact
Name of contact person
| 1st name | AKRIA |
| Middle name | |
| Last name | SUGAYA |
Organization
Jichi Medical University, School of Medicine
Division name
Department of Cardiovascular Surgery,
Zip code
329-0498
Address
Yakushiji 3311-1, Shimotsuke, Tochigi
TEL
+81-285-58-7368
Homepage URL
sugaya@jichi.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Surgery, Jichi Medical University, Shimotsuke, Japan.
Institute
Department
Personal name
Funding Source
Organization
Self-adjustment
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
The Support Center for Clinical Investigation (SCCI)
Address
Yakushiji 3311-1, Shimotsuke, Tochigi
Tel
0285-58-7550
shien@jichi.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
| 2022 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
In NT-SVG, the adventitia and perivascular adipose tissue were thicker, while in CSVG they were thinner. In NT-SVG, numerous vasa vasorum were observed in transverse and longitudinal sections in the adventitia and perivascular adipose tissue layers.
There was a significant difference in the vasa vasorum volume between the two groups (NT-SVG group: 0.0023 [IQR: 0.0015 to 0.0045 mm3] and Conventional SVG group: 0.0003 [IQR: 0.0001 to 0.0010 mm3], P=0.048).
Results date posted
| 2024 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
artery_mm3
artery_mm
artery_D1
artery_D2
vv volume
vv volume per 1mm of graft
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052805
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/03/20 | 臨床研究等計画書2023-1203.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/03/24 | UMIN登録.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/03/24 | 症例データ仕様書.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/52805
