UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052461 |
|---|---|
| Receipt number | R000059882 |
| Scientific Title | Validation of the anatomical merkmal of anterolateral popliteal artery puncture (retrospective study with contrast-enhanced CT). |
| Date of disclosure of the study information | 2023/10/12 |
| Last modified on | 2024/11/20 20:06:42 |
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Basic information
Public title
Validation of the anatomical merkmal of anterolateral popliteal artery puncture (retrospective study with contrast-enhanced CT).
Acronym
Validation of the anatomical merkmal of anterolateral popliteal artery puncture (retrospective study with contrast-enhanced CT).
Scientific Title
Validation of the anatomical merkmal of anterolateral popliteal artery puncture (retrospective study with contrast-enhanced CT).
Scientific Title:Acronym
Validation of the anatomical merkmal of anterolateral popliteal artery puncture (retrospective study with contrast-enhanced CT).
Region
| Japan |
Condition
Condition
peripheral arterial disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study the anatomical merkmal of the knee artery puncture technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hitting rate of the popliteal artery using the Merkmal method.
Key secondary outcomes
Vessel diameter and depth of the popliteal artery
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing contrast-enhanced CT of the lower limb arteries.
Key exclusion criteria
Patients with occlusion of the popliteal artery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamazaki |
Organization
Akita Cerebrospinal and Cardiovascular Center
Division name
cardiology
Zip code
010-0874
Address
6-10, Senshu-Kubota-Machi, Akita, Akita, Japan
TEL
+819096340772
circulation_777@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamazaki |
Organization
Akita Cerebrospinal and Cardiovascular Center
Division name
cardiology
Zip code
010-0874
Address
6-10, Senshu-Kubota-Machi, Akita, Akita, Japan
TEL
+819096340772
Homepage URL
circulation_777@yahoo.co.jp
Sponsor or person
Institute
Akita Cerebrospinal and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Akita Cerebrospinal and Cardiovascular Center
Address
6-10 Sensyu-Kubota-Machi
Tel
+819096340772
circulation_777@yahoo.co.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
| 2023 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
https://doi.org/10.1177/15266028241295917
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1177/15266028241295917
Number of participants that the trial has enrolled
56
Results
We retrospectively validated the Merkmal method in 108 limbs of 56 patients who underwent contrast enhanced lower limb CT at our hospital. The hit rate was 66.5%, the mean diameter of the popliteal artery was 4.6mm, the mean distance from the skin to the popliteal artery was 48.6 mm, and the mean angle of lateral obliquity was 57.3.
Results date posted
| 2024 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively validated the Merkmal method in 108 limbs of 56 patients who underwent contrast-enhanced lower limb CT at our hospital.
Participant flow
We retrospectively validated the Merkmal method in 108 limbs of 56 patients who underwent contrast-enhanced lower limb CT at our hospital.
Adverse events
none
Outcome measures
The primary endpoint was the hit rate, defined as the ratio of the area of the popliteal artery in the ROI on 3D CT divided by the area of the popliteal artery at the same level on contrast-enhanced CT. The secondary endpoints were the diameter of the popliteal artery, its distance from the skin, and the angle of obliquity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 11 | 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 | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059882
