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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name