UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016264 |
|---|---|
| Receipt number | R000018874 |
| Scientific Title | Clinical study to investigate the efficacy and safety of iliac stenting in patients with peripheral arterial disease |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2017/07/24 10:18:43 |
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Basic information
Public title
Clinical study to investigate the efficacy and safety of iliac stenting in patients with peripheral arterial disease
Acronym
Clinical study to investigate the efficacy and safety of iliac stenting in patients with peripheral arterial disease
Scientific Title
Clinical study to investigate the efficacy and safety of iliac stenting in patients with peripheral arterial disease
Scientific Title:Acronym
Clinical study to investigate the efficacy and safety of iliac stenting in patients with peripheral arterial disease
Region
| Japan |
Condition
Condition
Peripheral arterial disease(PAD), Arteriosclerosis obliterans(ASO)
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of iliac stenting in patients with peripheral arterial disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
12-month restenosis rate
Key secondary outcomes
procedural success rate, adverse events, Death within 30 days, MALE
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Iliac nitinol stent
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
(1) PAD (Rutherford1-4) due to iliac stenosis or occlusion
(2) Insufficiency of conservative treatment
(3) The patients obtained informed consent
(4) The age over 20 years old
Key exclusion criteria
(1) PAD (Rutherford5,6)
(2) The patients with bleeding disorder or the difficulty of taking the antiplatelet or anticoagulation therapy
(3) eGFR < 30 mL/min/1.73m2, except HD patients
(4) severe calcification
(5) Nitinol or nickel allergy
(6) The patients with the difficulty of 1 year follow up
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Maehara |
Organization
Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
(81)92-642-5466
maehara@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Matsumoto |
Organization
Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
(81)92-642-5466
Homepage URL
takum@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 01 | Month | 20 | 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
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | 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
| 2015 | Year | 01 | Month | 19 | Day |
Last modified on
| 2017 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018874
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
