UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054588 |
|---|---|
| Receipt number | R000061997 |
| Scientific Title | Evaluation of lower limb vascular characteristics during atherectomy-ablative angioplasty catheter (JETSTREAM) using optical coherence tomography. |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2025/02/19 23:51:51 |
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Basic information
Public title
Evaluation of lower limb vascular characteristics during atherectomy-ablative angioplasty catheter (JETSTREAM) using optical coherence tomography.
Acronym
Evaluation of lower limb vascular characteristics during atherectomy-ablative angioplasty catheter (JETSTREAM) using optical coherence tomography.
Scientific Title
Evaluation of lower limb vascular characteristics during atherectomy-ablative angioplasty catheter (JETSTREAM) using optical coherence tomography.
Scientific Title:Acronym
Evaluation of lower limb vascular characteristics during atherectomy-ablative angioplasty catheter (JETSTREAM) using optical coherence tomography.
Region
| Japan |
Condition
Condition
Lower extremity artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the changes in luminal characteristics of the vessels during JETSTREAM using OFDI in LEAD patients who underwent EVT using JETSTREAM.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in vascular lumen area assessed by OFDI before and after JETSTREAM treatment.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients who underwent EVT using JETSTREAM at Hyogo Awaji Medical Centre between August 2023 and May 2024 and who had OFDI as an intravascular imaging device at the time of treatment.
Key exclusion criteria
Cases where OFDI images are difficult to analyse due to poor blood cell removal.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
HYOGO PREFECTURAL AWAJI MEDICAL CENTER
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
TEL
09039981922
k722black@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
TEL
09039981922
Homepage URL
k722black@yahoo.co.jp
Sponsor or person
Institute
Hyogo Prefectural Awaji Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Hyogo Prefectural Awaji Medical Center
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
Tel
0799-22-1200
Awaji_hos@pref.hyogo.lg.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 | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/ccd.31460
Number of participants that the trial has enrolled
27
Results
There were 186 FPs, 753 CPs, and 563 ECNs. The acquired lumen gain after all atherectomy steps was significantly larger in the ECNs group than in the CPs and FPs groups. ECNs had the strongest effect on the variability in the lumen gain. In the effect of wire bias on the degree of debulking, a significant correlation was observed between wire distance and lumen gain in 1.85- and 2.4-mm BD atherectomy procedures. However, in the 2.4-mm BU procedure, no significant correlation was recorded.
Results date posted
| 2025 | Year | 02 | Month | 19 | Day |
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
Main results already published
Date of protocol fixation
| 2024 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who underwent EVT using JETSTREAM at Hyogo Awaji Medical Centre between August 2023 and June 2024 and who had OFDI as an intravascular imaging device at the time of treatment will be included.
The primary endpoint will be the change in vessel lumen area assessed by OFDI before and after JETSTREAM treatment.
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061997
