UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012746 |
|---|---|
| Receipt number | R000014895 |
| Scientific Title | Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia -Multicenter Prospective Study- |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2019/01/07 09:50:57 |
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Basic information
Public title
Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia -Multicenter Prospective Study-
Acronym
Predictor of Wound Healing in Patients with Critical Limb Ischemia -Multicenter Prospective Study-
Scientific Title
Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia -Multicenter Prospective Study-
Scientific Title:Acronym
Predictor of Wound Healing in Patients with Critical Limb Ischemia -Multicenter Prospective Study-
Region
| Japan |
Condition
Condition
Critical Limb Ischemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Clinical Impact of Post Procedural Peripheral Vascular Flow Reserve on Wound Healing Following Infrapopliteal Intervention in Patients with Critical Limb Ischemia by using a pressure/temprature sensor tipped tipped guidewire
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between Vascular Flow Reserve (VFR) and woundhealing within 3months
Key secondary outcomes
1.Reoccurence of wound within 1year after endovascular treatment
2.MAE (Major adverse event: death,acute myocardial infarction, cerebrovascular event, target lesion revascularization, heart failure)
3.Major limb amputation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To evaluate the vascular flow reserve after endovascular treatment by using a pressure/temperature sensor-tipped-guidewire
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
Patients with critical limb ischemia underwent endovascular therapy for below-the-knee artery
Key exclusion criteria
Patients with rutherford 6 criteria
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Fukunaga |
Organization
Morinomiya Hospital
Division name
Cardiovascular Division
Zip code
Address
2-1-88, Morinomiya, Joto-ku, Osaka
TEL
0669690111
fukunagahothot@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fukunaga |
Organization
Morinomiya Hospital
Division name
Cardiovascular Division
Zip code
Address
2-1-88, Morinomiya, Joto-ku, Osaka
TEL
0669690111
Homepage URL
fukunagahothot@yahoo.co.jp
Sponsor or person
Institute
Japan Endovascular Treatment Conference
Institute
Department
Personal name
Funding Source
Organization
Japan Endovascular Treatment Conference
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
Address
Tel
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
兵庫医科大学 （兵庫県）
岸和田徳洲会病院（大阪府）
関西労災病院（兵庫県）
森之宮病院（大阪府）
明和病院（兵庫県）
坂総合病院（宮城県）
京都第二赤十字病院（京都府）
筑波メディカルセンター（茨城県）
東京労災病院（東京都）
信州大学（長野県）
大阪府立急性期総合医療センター（大阪府）
兵庫県立淡路医療センター（兵庫県）
多根総合病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 01 | 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
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
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 03 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014895
