UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043416
Receipt number R000049570
Scientific Title The optimal strategy with VIABAHN VBX covered stent for complex aort-iliac artery disease by endovascular procedure
Date of disclosure of the study information 2021/03/01
Last modified on 2022/10/17 22:29:39

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Basic information

Public title

The optimal strategy with VIABAHN VBX covered stent for complex aort-iliac artery disease by endovascular procedure

Acronym

AVOCADO-II study

Scientific Title

The optimal strategy with VIABAHN VBX covered stent for complex aort-iliac artery disease by endovascular procedure

Scientific Title:Acronym

AVOCADO-II study

Region

Japan


Condition

Condition

Peripheral artery disease

Classification by specialty

Cardiology Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of VIABAHN VBX stent

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

One year primary patency

Key secondary outcomes

One year CD-TLR
Procedual complication
IVUS data


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

1) Peripheral artery disease (Rutherford category 2 to 6)
2) Endovascular procedure using VIABAHN VBX stents for aorto-iliac artery disease

Key exclusion criteria

no angiography case

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Tomoi

Organization

Kokura Memorial Hospital

Division name

Cardiology

Zip code

802-0001

Address

3-2-1 Asano, Kokurakita-ku Kitakyushu, Fukuoka

TEL

0935112000

Email

mbxtg263@ybb.ne.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Tomoi

Organization

Kokura Memorial Hospital

Division name

Cardiology

Zip code

802-0001

Address

3-2-1 Asano, Kokurakita-ku Kitakyushu

TEL

0935112000

Homepage URL


Email

mbxtg263@ybb.ne.jp


Sponsor or person

Institute

Kokura Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

Kokura Memorial Hospital

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

Kokura Memorial Hospital

Address

3-2-1 Asano, Kokurakita-ku Kitakyushu

Tel

0935112000

Email

mbxtg263@ybb.ne.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



Other administrative information

Date of disclosure of the study information

2021 Year 03 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

No longer recruiting

Date of protocol fixation

2020 Year 05 Month 30 Day

Date of IRB

2020 Year 03 Month 18 Day

Anticipated trial start date

2020 Year 07 Month 01 Day

Last follow-up date

2025 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2021 Year 02 Month 22 Day

Last modified on

2022 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049570


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name