UMIN-CTR Clinical Trial

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
Email	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
Email	mhigashi@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University Ibaraki Medical Center Department of Cardiology
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028994