UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007365
Receipt number R000007771
Scientific Title Effect of high-pressure balloon angioplasty on patency rate at one year in hemodialysis patients with auto-vascular access stenosis
Date of disclosure of the study information 2012/02/23
Last modified on 2019/04/18 12:53:46

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Basic information

Public title

Effect of high-pressure balloon angioplasty on patency rate at one year in hemodialysis patients with auto-vascular access stenosis

Acronym

High pressure angioplasty and patency rate

Scientific Title

Effect of high-pressure balloon angioplasty on patency rate at one year in hemodialysis patients with auto-vascular access stenosis

Scientific Title:Acronym

High pressure angioplasty and patency rate

Region

Japan


Condition

Condition

Vascular access stenosis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify whether high pressure balloon angioplasty for auto-vascular access stenosis is effective on a patency rate.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The 1-year patency rate after balloon angioplasty

Key secondary outcomes

Primary success rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Balloons are inflated to the pressure of 8 atm (low pressure group) or 30 atm (high pressure group)

Interventions/Control_2

In the case of restenosis the balloon size will be increased by 1 mm and the balloon inflated with same pressure range as the initial treatment

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

Patients who underwent vascular access failure in Brescia-cimino fistula and satisfy the indication criteria for PTA established by the Japanese Society for Dialysis Therapy.
All patients are treated with PTA for the first time.

Key exclusion criteria

Patients who underwent PTA before.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Takao
Middle name
Last name MASAKI

Organization

Hiroshima University Hospital

Division name

Department of Nephrology

Zip code

734-8551

Address

1-2-3 Kasumi Minami-ku, Hiroshima,

TEL

082-257-1506

Email

masakit@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Shigehiro
Middle name
Last name DOI

Organization

Hiroshima University Hospital

Division name

Department of Blood Purification

Zip code

734-8551

Address

1-2-3 Kasumi Minami-ku, Hiroshima,

TEL

082-257-5960

Homepage URL


Email

sdoi@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of Nephrology, Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

No

Name of secondary funder(s)

No


IRB Contact (For public release)

Organization

Hiroshima University Hospital

Address

1-2-3 Kasumi Minamiku, Hiroshima

Tel

082-257-5555

Email

hugcp@hiroshima-u.ac.jp


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

広島大学病院(広島県)、尾道クリニック(広島県)、尾道総合病院(広島県)、中央内科クリニック(広島県)、呉共済病院(広島県)、呉医療センター(広島県)、博愛クリニック(広島県)、県立広島病院(広島県)、一陽会原田病院(広島県)、広島西医療センター(広島県)、あかね会土谷総合病院


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 23 Day


Related information

URL releasing protocol

https://journals.sagepub.com/doi/full/10.1177/1129729818760976?url_ver=Z39.88-2003&rfr_id=ori%3Arid%

Publication of results

Published


Result

URL related to results and publications

https://journals.sagepub.com/doi/full/10.1177/1129729818760976?url_ver=Z39.88-2003&rfr_id=ori%3Arid%

Number of participants that the trial has enrolled

71

Results

The 12-month patency rates showed no significant difference between the low- and high-pressure groups. In the low-pressure group, the patency rate was not different between patients with complete dilation and residual stenosis. The Cox proportional hazard model revealed that the 12-month patency rate was associated with the stenosis diameter and the presence of diabetes.

Results date posted

2019 Year 04 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

After written informed consent was obtained, the patients were assigned into the low- or high-pressure group (dilation at 8 atm or 30 atm, respectively) according to the allocation table, taking sex and the presence of diabetes mellitus into consideration.

Participant flow

Patency period was defined as a term from PTA to next PTA or surgical revision. In addition to age and presence of diabetes mellitus, we collected the data of the location, diameters of stenosis site, its proximal and distal veins, and length of stenosis. We also investigated presence complicate dilation, pressure when achieved complete dilation, and an incidence of complication.

Adverse events

No

Outcome measures

The 12 months patency rate between the low and high pressure groups were compared by Kaplan-Meier method, following log-rank test. Similarly, in the low-pressure group, the 12-months patency rate between patients with complete dilation and those with incomplete dilation. Cox proportional hazard analyses were performed to identify factors which are independently associated with the 12 months patency. Analyses were performed using SPSS software.

Plan to share IPD

No

IPD sharing Plan description

No


Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 05 Month 11 Day

Date of IRB

2001 Year 10 Month 20 Day

Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2016 Year 11 Month 01 Day

Date of closure to data entry

2016 Year 12 Month 01 Day

Date trial data considered complete

2016 Year 12 Month 01 Day

Date analysis concluded

2016 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 02 Month 23 Day

Last modified on

2019 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007771


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name