UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003205 |
|---|---|
| Receipt number | R000003886 |
| Scientific Title | Comparison of the midterm patency after primary nitinol stenting for superficial femoral artery (intraluminal v.s. subintimal angioplasty assessed by intravascular ultrasound) |
| Date of disclosure of the study information | 2010/02/18 |
| Last modified on | 2010/02/18 07:48:53 |
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Basic information
Public title
Comparison of the midterm patency after primary nitinol stenting for superficial femoral artery (intraluminal v.s. subintimal angioplasty assessed by intravascular ultrasound)
Acronym
Super FACT registry (SUPERficial Femoral Artery Chronic Total occlusion registry)
Scientific Title
Comparison of the midterm patency after primary nitinol stenting for superficial femoral artery (intraluminal v.s. subintimal angioplasty assessed by intravascular ultrasound)
Scientific Title:Acronym
Super FACT registry (SUPERficial Femoral Artery Chronic Total occlusion registry)
Region
| Japan |
Condition
Condition
PAD (Peripheral artery disease)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate comparison of the midterm patency regarding primary nitinol stenting for the intraluminal or subintimal space of superficial femoral artery(SFA)-chronic total occlusion (CTO) lesion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary and Secondary patency
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intraluminalgroup
Interventions/Control_2
subintimal group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Symptoms due to SFA-CTO lesion (Rutherford 2-6) that affected the quality of life in spite of excises and medications
De novo SFA-CTO lesion
Key exclusion criteria
angioplasty alone
Restenotic lesions
acute or sub-acute limb ischemia
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular center
Zip code
Address
3-1-69, Inabaso, Amagasaki city, Hygo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular center
Zip code
Address
TEL
06-6416-1221
Homepage URL
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 02 | Month | 18 | 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
| 2007 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | 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
| 2010 | Year | 02 | Month | 18 | Day |
Last modified on
| 2010 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003886
