UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025204 |
|---|---|
| Receipt number | R000028994 |
| Scientific Title | Angiography follow up and intravascular imaging modality indicate optimal endovascular direction in femoropopliteal artery disease |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2021/06/13 11:33:51 |
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Basic information
Public title
Angiography follow up and intravascular imaging modality indicate optimal endovascular direction in femoropopliteal artery disease
Acronym
Phalcon Registry
Scientific Title
Angiography follow up and intravascular imaging modality indicate optimal endovascular direction in femoropopliteal artery disease
Scientific Title:Acronym
Phalcon Registry
Region
| Japan |
Condition
Condition
Peripheral artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the restenosis rate by angiography one year after endovascular treatment in femoropopliteal artery disease.
To cralify the contemporary real world restenosis rate and the predictive values of restenosis or revascularization event with intravascular ultrasounds data and data during endovascular treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1Restenosis rate one year after endovascular treatment by angiography with QVA system
2Revascularization event with endovascular or surgical therapy within one year after endovascular treatment
Key secondary outcomes
1ABI(3,6,9,12months after endovascular treatment)
2Change of lower limb sympton
3Acute limb event
4Death, Myocardial Infarction, stroke event
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with agreement for study
Key exclusion criteria
1 Patients without agreement for study
2 inappropriate patients determined from study director
3 patients within 20 years old
4 A life expectancy within 1 year
5 acute limb ischemia patients
6 inappropriate patients with contrast media usage
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Aihara |
Organization
Tsukuba Medical Center Hospital
Division name
Cardiology
Zip code
Address
3-1 1chome amakubo Tuskuba city Ibaraki Prefecture
TEL
029-851-3511
hideaki.aihara@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiaki Higashitani |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Department of Cardiology
Zip code
Address
20-1 3chome Amichochuo Inashikigun Ibaraki Prefecture
TEL
029-887-1161
Homepage URL
mhigashi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Ibaraki Medical Center
Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
TOMA-Code study group
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
筑波メディカルセンター（茨城県）
東京労災病院 （東京都）
東京医科大学茨城医療センター（茨城県）
武蔵野赤十字病院（東京都）
河北総合病院（東京都）
同愛記念病院（東京都）
国家公務員共済組合連合会虎ノ門病院（東京都）
聖路加国際病院（東京都）
横須賀共済病院（神奈川県）
総合病院国保旭中央病院（千葉県）
おおたかの森病院（千葉県）
船橋市立医療センター（千葉県）
佐渡総合病院（新潟県）
東京都済生会中央病院（東京都）
西新井ハートセンター（東京都）
前橋赤十字病院（群馬県）
湘南鎌倉総合病院（神奈川県）
新東京病院（東京都）
太田記念病院（群馬県）
東京医科大学病院（東京都）
かわぐち心臓呼吸器病院（埼玉県）
埼玉県済生会栗橋病院（埼玉県）
総合東京病院（東京都）
榊原記念病院（東京都）
小田原循環器病院（神奈川県）
日本医大武蔵小杉病院（神奈川県）
鶴岡協立病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 09 | 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
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 04 | Month | 29 | Day |
Other
Other related information
End of study
Management information
Registered date
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2021 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028994
