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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013438
Receipt No. R000015689
Scientific Title Prevention of Restenosis by Concomitant Tibial artery interventions after EndoVascular Treatment in FemoroPopliteal artery diseases complicated with Poor Runoff
Date of disclosure of the study information 2014/03/17
Last modified on 2015/10/13

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Basic information
Public title Prevention of Restenosis by Concomitant Tibial artery interventions after EndoVascular Treatment in FemoroPopliteal artery diseases complicated with Poor Runoff
Acronym ConTibi-FP
Scientific Title Prevention of Restenosis by Concomitant Tibial artery interventions after EndoVascular Treatment in FemoroPopliteal artery diseases complicated with Poor Runoff
Scientific Title:Acronym ConTibi-FP
Region
Japan

Condition
Condition peripheral artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the Prevention of Restenosis by Concomitant Tibial artery interventions after EndoVascular Treatment in FemoroPopliteal artery diseases complicated with Poor Runoff
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Restenosis rate of the target femoro-popliteal artery by duplex scan at one year
Key secondary outcomes death, myocardial infarction, bleeding
lower limb event(revascularization, acute limb ischemia), lower limb amptation, lower limb sympton(WIQ score)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Randomized Control Arm with concomitant below the knee artery interventions
Interventions/Control_2 Randomized Control Arm without concomitant below the knee artery interventions
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 1)patients required endovacular treatment for femoro-popliteal artery complicated with all ipsilateral below-the-knee artery feeding under anckle narrowed more than 90%
2)patients with agreement for this study
Key exclusion criteria 1)Life expectancy within 6months
2)allergy of contrast agents
3)under 20 years old
4)inappropiriate patients determined from study director
5)patients unavailable of antiplatelet agents and anticoagulant
6)Critical limb ischemia patients that revascularization to below-the-knee artery is scheduled
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Higashitani
Organization Sakakibara Heart Institute
Division name Department of Cardiology
Zip code
Address 3-16-1 asahi-cho Futyu-shi Tokyo
TEL 042-314-3111
Email mhigashi@shi.heart.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Clinical Trials Support Office
Organization Sakakibara Heart Institute
Division name Clinical Trials Support Office
Zip code
Address 3-16-1 asahi-cho Futyu-shi Tokyo
TEL 042-314-3111
Homepage URL
Email tikenjim@shi.heart.or.jp

Sponsor
Institute Sakakibara Heart Institute
Institute
Department

Funding Source
Organization Japan Reserch Promotion Society for Cardiovascular disease
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 17 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 Terminated
Date of protocol fixation
2014 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 17 Day
Last modified on
2015 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015689

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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