UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013438 |
|---|---|
| Receipt number | 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 06:22:11 |
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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
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
tikenjim@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015689
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
