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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023702
Receipt No. 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

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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
Email 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
Email masahiko-fujihara@themis.ocn.ne.jp

Sponsor
Institute Kishiwada Tokushukai Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027295

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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