UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052799 |
|---|---|
| Receipt number | R000060226 |
| Scientific Title | Investigation of the Optical Frequency Domain Imaging-guided drug-coated balloon therapy for femoropopliteal in-stent restenosis |
| Date of disclosure of the study information | 2023/11/14 |
| Last modified on | 2023/11/14 17:52:35 |
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Basic information
Public title
INFINITY ISR
Acronym
INFINITY ISR
Scientific Title
Investigation of the Optical Frequency Domain Imaging-guided drug-coated balloon therapy for femoropopliteal in-stent restenosis
Scientific Title:Acronym
INFINITY ISR
Region
| Japan |
Condition
Condition
In-stent restenosis: ISR
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the Optical Frequency Domain Imaging-guided drug-coated balloon therapy for femoropopliteal in-stent restenosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
at 12-month follow-up
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Over 20 years old
-Patients with symptomatic lower extremity arteriosclerosis obliterans (Rutherford Classification 2-5)
-Patients treated with OFDI-guided DCB for ISR of the femoral popliteal artery (any type of stent presenting ISR)
Key exclusion criteria
-Lesions with confirmed stent fractures of type III or greater
-Lesions with two or more stents stacked on top of each other
-Lesions implanted with a combination of two or more stents
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nakama |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Cardiology
Zip code
279-0001
Address
3-4-32 Todaijima, Urayasu-City, Chiba
TEL
047-351-3101
tatsuya_nakama@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nakama |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Cardiology
Zip code
279-0001
Address
3-4-32 Todaijima, Urayasu-City, Chiba
TEL
047-351-3101
Homepage URL
tatsuya_nakama@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
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
Tokyo Bay Urayasu Ichikawa Medical Center
Address
3-4-32 Todaijima, Urayasu-City, Chiba
Tel
047-351-3101
tatsuya_nakama@med.miyazaki-u.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
| 2023 | Year | 11 | Month | 14 | 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
116
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Observational study
Target population:Symptomatic atherosclerosis obliterans treated with an optical coherence tomography-guided, drug-coated balloon for in-stent restenosis in the femoral popliteal artery territory
Management information
Registered date
| 2023 | Year | 11 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060226
