UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023702 |
|---|---|
| Receipt number | R000027295 |
| Scientific Title | Angiographic dissection patterns and associated patency outcomes post balloon angioplasty for superficial femoral artery lesions |
| Date of disclosure of the study information | 2016/08/20 |
| Last modified on | 2018/02/20 10:13:54 |
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Basic information
Public title
Angiographic dissection patterns and associated patency outcomes post balloon angioplasty for superficial femoral artery lesions
Acronym
Dissection Study
Scientific Title
Angiographic dissection patterns and associated patency outcomes post balloon angioplasty for superficial femoral artery lesions
Scientific Title:Acronym
Dissection Study
Region
| Japan |
Condition
Condition
Symptomatic peripheral arterial disease with SFA
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the angiographic dissection patterns post balloon angioplasty for superficial temporal artery (SFA) lesions, the clinical outcome associated with each dissection pattern, and predictive factors of severe dissection.
Basic objectives2
Others
Basic objectives -Others
Cross sectional study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary measure was the angiographic dissection pattern following balloon angioplasty.
Key secondary outcomes
Secondary measures were [1] primary patency and clinically driven target lesion revascularization (TLR) among balloon-alone procedure patients based on dissection patterns, and [2] predictive factors for severe dissection.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Symptoms were classified based on the Rutherford category classifications, and all patients were between class 2 and 6.The main inclusion criteria were single or sequential de novo lesions (>70% diameter reduction or occlusion) in the SFA segment for a reference vessel diameter of 3-7mm
Key exclusion criteria
Cases treated by a direct stent implantation strategy without balloon angioplasty or no angiography after balloon angioplasty was excluded from this study. In-stent restenosis lesion cases were also excluded.
Target sample size
621
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Fujihara |
Organization
Kishiwada Tokushukai Hospital
Division name
Cardiology
Zip code
Address
4-27-1 Kamoricho Kishiwada city Osaka
TEL
072-445-9915
masahiko-fujihara@themis.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Fujihara |
Organization
Kishiwada Tokushukai Hospital
Division name
Cardiology
Zip code
Address
4-27-1 Kamoricho Kishiwada city Osaka
TEL
072-445-9915
Homepage URL
masahiko-fujihara@themis.ocn.ne.jp
Sponsor or person
Institute
Kishiwada Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
坂総合病院 循環器内科 佐々木伸也
東京労災病院 循環器科 宇都宮誠
関西労災病院 循環器内科 南都清範
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2015 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a retrospective, multicenter, clinical investigation.
Management information
Registered date
| 2016 | Year | 08 | Month | 20 | Day |
Last modified on
| 2018 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027295
