UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019931
Receipt number R000023010
Scientific Title Safety and efficacy of the transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: A radial ultrasound follow-up study
Date of disclosure of the study information 2015/12/01
Last modified on 2019/12/18 21:58:10

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Basic information

Public title

Safety and efficacy of the transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: A radial ultrasound follow-up study

Acronym

Safety and efficacy of the sheathless transradial percutaneous coronary intervention for acute coronary syndrome

Scientific Title

Safety and efficacy of the transradial percutaneous coronary intervention using sheathless guiding catheters for acute coronary syndrome: A radial ultrasound follow-up study

Scientific Title:Acronym

Safety and efficacy of the sheathless transradial percutaneous coronary intervention for acute coronary syndrome

Region

Japan


Condition

Condition

Acute coronary syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Feasibility of the sheathless transradial percutaneous coronary intervention (PCI) in patients with acute coronary syndrome

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1) Initial success of the procedure
(2) Coronary ostial dissection
(3) Access-site complications at 1- or 2-day follow-up, including radial artery occlusion, arteriovenous fistula, local infection, pseudoaneurysm, radial access site bleeding and critical upper limb ischemia

Key secondary outcomes

(1) Access-site complications at 30-day follow-up
(2) Major adverse cardiac events at 30-, 180-day and 1-year follow-up, including all-cause death, myocardial infarction, stent thrombosis and target lesion revascularization


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients who suffered acute coronary syndrome and underwent ad hoc PCI via radial artery

(2) Ad hoc PCI was done using a 6.5-Fr or 7.5-Fr sheathless guiding catheter (Sheathless Eaucath; Asahi Intecc).

(1) and (2)

Key exclusion criteria

(1) The patients who underwent the procedure via femoral artery

(2) The patients who did not proceed to PCI (no coronary artery disease and patients advised for CABG)

(1) or (2)

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaname Takizawa, MD

Organization

Sendai Kousei Hospital

Division name

Department of Cardiology

Zip code


Address

4-15, Hirose-machi, Sendai, 980-0873, Japan.

TEL

81-22-222-6181

Email

kanametaki@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tsuyoshi Isawa, MD

Organization

Sendai Kousei Hospital

Division name

Department of Cardiology

Zip code


Address

4-15, Hirose-machi, Sendai, 980-0873, Japan.

TEL

81-22-222-6181

Homepage URL


Email

isa_tsuyo@yahoo.co.jp


Sponsor or person

Institute

Sendai Kousei Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

仙台厚生病院(宮城県), Sendai Kousei Hospital (Miyagi prefecture, Japan)


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

Cardiovasc Interv Ther. 2019 Dec 6. doi: 10.1007/s12928-019-00632-7. [Epub ahead of print]

Number of participants that the trial has enrolled

500

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 12 Month 06 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 01 Month 10 Day

Date of IRB

2015 Year 01 Month 12 Day

Anticipated trial start date

2015 Year 01 Month 12 Day

Last follow-up date

2019 Year 12 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: observational study

Patient selection: Consecutive patients with acute coronary syndrome who visited our hospital and underwent transradial primary PCI from January 2015 were enrolled.

Measurement: major caydiovascular event (All-cause death, myocardial infarction, stent thrombosis and target lesion revascularization), access-site complications, including radial artery occlusion


Management information

Registered date

2015 Year 11 Month 25 Day

Last modified on

2019 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023010


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name