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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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