UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia -Multicenter Prospective Study-
Title of the study (Brief title)	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	Masashi Fukunaga
Organization	Morinomiya Hospital
Division name	Cardiovascular Division
Address	2-1-88, Morinomiya, Joto-ku, Osaka
TEL	0669690111
Email	fukunagahothot@yahoo.co.jp

Public contact
Name of contact person	Masashi Fukunaga
Organization	Morinomiya Hospital
Division name	Cardiovascular Division
Address	2-1-88, Morinomiya, Joto-ku, Osaka
TEL	0669690111
Homepage URL
Email	fukunagahothot@yahoo.co.jp

Sponsor
Institute	Japan Endovascular Treatment Conference
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014895