UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026397 |
|---|---|
| Receipt number | R000030331 |
| Scientific Title | Multi-institutional prospective observational study for Zenith Spiral Z stent graft deployed in external iliac artery |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/09/05 10:55:43 |
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Basic information
Public title
Multi-institutional prospective observational study for Zenith Spiral Z stent graft deployed in external iliac artery
Acronym
Multi-institutional prospective observational study for Zenith Spiral Z stent graft deployed in external iliac artery
Scientific Title
Multi-institutional prospective observational study for Zenith Spiral Z stent graft deployed in external iliac artery
Scientific Title:Acronym
Multi-institutional prospective observational study for Zenith Spiral Z stent graft deployed in external iliac artery
Region
| Japan |
Condition
Condition
Patients with Zenith Spiral Z stent graft deployed in external iliac artery during EVAR
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of Zenith Spiral Z stent graft deployed in external iliac artery during EVAR.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary, primary-assisted, and secondary patency of Zenith Spiral Z stent graft
Key secondary outcomes
intraoperative major adverse events and additional procedures
perioperative major adverse events
aneurysm related event and reintervention within 1 year after EVAR
incidence of intraoperative and early endoleaks
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
Patients with Zenith Spiral Z stent graft deployed in external iliac artery during EVAR for AAA or IAA.
Key exclusion criteria
1. Patients declining participation to the research.
2. Etiology of AAA and IAA other than atherosclerosis (ex: infection, vasculitis, dissection, etc.)
3. Patients unfit for the research decided by the physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Onitsuka |
Organization
University of Kurume
Division name
Departmentof Cardiovascular surgery
Zip code
955-8463
Address
67 Asahi, Kurume, Fukuoka, Japan
TEL
0942-35-3311
onitti@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Fujimura |
Organization
Saiseikai Central Hospital
Division name
Department of Cardiovascular Surgery
Zip code
108-0073
Address
1-4-17 Mita, Minato, Tokyo, Japan
TEL
03-3451-8211
Homepage URL
naokif0212@gmail.com
Sponsor or person
Institute
Department of Cardiovascular Surgery, Saiseikai Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Surgery, Saiseikai Central 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
IRB at Saiseikai Central Hospital
Address
1-4-17, Mita, Minatoku, Tokyo
Tel
03-3451-8211
tikenjimu@saichu.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
東京都済生会中央病院（東京都）、久留米大学心臓血管外科（福岡県）、飯塚病院心臓血管外科（福岡県）、イムス富士見総合病院血管外科（東京都）、大分大学放射線医学講座（大分県）、大阪労災病院末梢血管外科（大阪府）、鹿児島大学心臓血管外科（鹿児島県）、九州大学病院第2外科（福岡県）、川崎医科大学心臓血管外科（岡山県）、北里大学心臓血管外科（神奈川県）、熊本大学大学院生命科学研究部放射線診断学分野（熊本県）、慶應義塾大学外科（東京都）、済生会熊本病院心臓血管外科（熊本県）、済生会福岡総合病院血管外科（福岡県）、埼玉県立循環器・呼吸器病センター心臓血管外科（埼玉県）、榊原記念病院末梢血管外科（東京都）、佐賀大学心臓血管外科（佐賀県）、相模原協同病院血管外科（神奈川県）、市立函館病院心臓血管外科（北海道）、新百合ヶ丘病院血管外科（東京都）、総合病院土浦協同病院血管外科（茨城県）、練馬光が丘病院心臓血管外科（東京都）、千葉大学医学部附属病院心臓血管外科（千葉県）、帝京大学医学部心臓血管外科（東京都）、東京医科歯科大学血管外科（東京都）、東京慈恵会医科大学附属柏病院血管外科（千葉県）、東邦大学医療センター大森病院心臓血管外科（東京都）、東広島医療センター心臓血管外科（広島県）、福岡大学心臓血管外科（福岡県）、福岡和白病院心臓血管外科（福岡県）、防衛医科大学校病院心臓血管外科（埼玉県）、松山赤十字病院血管外科（愛媛県）、山口大学大学院器官病態外科血管外科（山口県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32759542/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32759542/
Number of participants that the trial has enrolled
65
Results
primary patency of 95.5% and a secondary patency of 100%, at 24 months. Buttock claudication occurred in 24.3% of the limbs treated at 1 month but decreased to 4.3% at 24 months.
Results date posted
| 2020 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients that had Spiral Z landing in EIA during EVAR
Participant flow
prospective observational study
Adverse events
none
Outcome measures
primary latency
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2017 | Year | 03 | Month | 04 | Day |
Last modified on
| 2020 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030331
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/09/05 | 2019.12.17 SpiralZ前向き申請書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/09/05 | 2.20 Spiral Z台帳.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/09/05 | UMIN用最新版統合Spiral Z台帳.xlsx |
