UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028851
Receipt number R000032993
Scientific Title Assessment of radial artery injury after transradial intervention : A frequency domain-optical coherence tomography and optical frequency domain imaging study.
Date of disclosure of the study information 2017/09/01
Last modified on 2017/11/12 11:04:52

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Basic information

Public title

Assessment of radial artery injury after transradial intervention : A frequency domain-optical coherence tomography and optical frequency domain imaging study.

Acronym

Assessment of radial artery injury after TRI using FD-OCT/OFDI.

Scientific Title

Assessment of radial artery injury after transradial intervention : A frequency domain-optical coherence tomography and optical frequency domain imaging study.

Scientific Title:Acronym

Assessment of radial artery injury after TRI using FD-OCT/OFDI.

Region

Japan


Condition

Condition

Consecutive patients with ischemic heart disease who underwent elective transradial coronary intervention using FD-OCT/OFDI

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Radial artery is commonly used as vascular route for coronary intervention because of lower incidence of vascular complications and its safety compared with transfemoral coronary intervention. However, little is known regarding the radial artery injury after transradial intervention. The aim of this study is to investigate the radial artery injury after TRI using FD-OCT/OFDI.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The primary endpoint is to assess the radial artery injury (intimal flap, medial dissection or thrombus) using FD-OCT/OFDI.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

FD-OCT/OFDI catheter is inserted through the sheath, and placed at the radial artery ostium. The sheath is extracted to a point of 1cm proximal to the puncture point. After continuous infusion of saline through the sheath, automated pull back(40mm/s) imaging is performed to examine the overall radial artery.

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

20 years-old <=

Age-upper limit

95 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with ischemic heart disease who are planned to undergo transradial coronary intervention

Key exclusion criteria

We excluded patients with serum creatinine > 2.0mg/dl or abnormal Allen test.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takatoshi Wakeyama

Organization

Japan Community Healthcare Organization Tokuyama Central Hospital

Division name

Division of Cardiology

Zip code


Address

1-1, Kodachou, Shunan, Yamaguchi, Japan

TEL

+81-834-28-4411

Email

wakeyama@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Takatoshi Wakeyama

Organization

Japan Community Healthcare Organization Tokuyama Central Hospital

Division name

Division of Cardiology

Zip code


Address

1-1, Kodachou, Shunan, Yamaguchi, Japan

TEL

+81-834-28-4411

Homepage URL


Email

wakeyama@hotmail.com


Sponsor or person

Institute

Japan Community Healthcare Organization Tokuyama Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Community Healthcare Organization Tokuyama Central Hospital

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


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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 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

2014 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 16 Day

Last follow-up date

2017 Year 09 Month 19 Day

Date of closure to data entry

2017 Year 09 Month 19 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 28 Day

Last modified on

2017 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032993


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name