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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008345
Receipt No. R000007421
Scientific Title National Hospital Organization Network Study for prospective registry of aoritc aneurysm repair
Date of disclosure of the study information 2012/07/05
Last modified on 2017/07/08

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Basic information
Public title National Hospital Organization Network Study for prospective registry of aoritc aneurysm repair
Acronym NHONW study for prospective registration of aortic aneurysm repair
Scientific Title National Hospital Organization Network Study for prospective registry of aoritc aneurysm repair
Scientific Title:Acronym NHONW study for prospective registration of aortic aneurysm repair
Region
Japan

Condition
Condition abdominal aortic aneurysm
Classification by specialty
Vascular surgery Cardiovascular surgery Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The chnge of surgical outcomes regarding repair of abdominal aortic aneurysm in introduction of endovascular repar technology into Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes aneurysm related mortality
Key secondary outcomes enlargement of aneurysmal diameter

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who had treatment for abdominal aortic and/or iliac artery aneurysm with the following criteria: maximum external diameter more than 5cm or 4-5cm with rapid enlargement, or saccular morphology which carried high risk of rupture. In some patients, they were treated for main location of common iliac artery aneurysm if their maximum size was more than twice the normal diameter.
Key exclusion criteria Patients who require concomittant repair of thoracic and/or thoracoabdominal aneurysm repair or who require reconstruction of abdominal branches.
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Handa, MD
Organization National Hospital Organization, Nagara Medical Center
Division name Department of Cardiovascular Surgery
Zip code
Address 1300-7, Nagara, Gifu, Japan
TEL +81-58-232-7755
Email nhanda111@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Handa, MD
Organization Nagara Medical Center
Division name Department of Cardiovascular Surgery
Zip code
Address 1300-7, Nagara, Gifu, Japan
TEL +81-58-232-7755
Homepage URL
Email nhanda11@nagara-lan.hosp.go.jp

Sponsor
Institute National Hopital Organization Network Group for abdominal aortic aneurysm
Institute
Department

Funding Source
Organization National Hopital Organization
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

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 国立病院機構北海道医療センター、金沢医療センター、長良医療センター、大阪医療センター、大阪南医療センター、岡山医療センター、岩国医療センター、呉医療センター、東広島医療センター、九州医療センター、熊本医療センター、鹿児島医療センター、浜田医療センター、

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 05 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
Though significant differences in patient characteristics between EVAR and open surgical group were noted, early results were satisfactory in both groups.
Proportion of EVAR in AAA repair increased from 0% into 48.8% over 8 years. Surgical death was comaprable after patient charaqcteristics were adjusted.Overall, indication of AAA repair was extended without increasing the hospital mortality.
Late sac enlargement of AAA after EVAR was assessed, which disclosed that about 20% of cases showed sac enlargement at 5 years. 
Late intervention was also assessed, which disclosed that late intervention was required in about 15% of patients after EVAR at 5 years. It include about 6% of surgical conversion such as graft replacement, sacotomy, femoro-femoral bypass or thrombectomy for graft occlusion.
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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2024 Year 12 Month 01 Day
Date of closure to data entry
2024 Year 12 Month 01 Day
Date trial data considered complete
2024 Year 12 Month 01 Day
Date analysis concluded
2025 Year 12 Month 01 Day

Other
Other related information The primary outcome measure was surgical mortality. It is defined as either any cause of death within 30days after operation or in-hospital mortality without discharge at any time. The secondary outcome measures included early morbidities, and intermediate term results. Details of treatments were described such as procedure time, volume of blood transfusion, and process of recovery including hours of respiratory management, length of intensive care unit stay (ICU stay), procedure failure requiring additional procedure during same hospitalization, and re-admission within 30days.

Management information
Registered date
2012 Year 07 Month 04 Day
Last modified on
2017 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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