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 | 2025/02/25 17:40:04 |
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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
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
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
149
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
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049570
