UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese registry of patients treated with endovascular or open repair for ruptured abdominal aortic aneurysm
Title of the study (Brief title)	JEWELRY study
Region	Japan

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

Objectives
Narrative objectives1	1)To explore the patients' status, treatment procedure selection, and the clinical results in real-world clinical setting in Japan. 2) To clarify the adequate selection of EVAR or open repair for ruptured abdominal aortic aneurysms in reflecting the patients' situation and anatomical conditions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	30 days mortality
Key secondary outcomes	In-hospital mortality 30 days MACE Length of hospital stay Survival rate at 3 year Aneursym-related even-free survival at 3 year

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	Ruptured abdominal aortic aneurysm
Key exclusion criteria	-Impending rupture case -Aneurysm previously treated -Ruptured aneurysm of external or internal iliac artery -Supra-renal aortic aneurysm -Died before entering operation room -Patient who do not agree to be enrolled in this study
Target sample size	2000

Research contact person
Name of lead principal investigator	Nobuyoshi Azuma
Organization	Asahikawa Medical University
Division name	Department of Vascular Surgery
Address	Midorigaoka Higash i2-1-1-1 Asahikawa Hokkaido
TEL	0166-68-2494
Email	nazuma@asahikawa-med.ac.jp

Public contact
Name of contact person	Chigusa Yamamoto
Organization	The Japanese Society for Vascular Surgery
Division name	Office
Address	Odakyudaiichiseimei Bld. 4F nishishinjyuku2-7-1 shinjyuku Tokyo
TEL	03-5989-0991
Homepage URL	http://www.jsvs.org/ja/enquete/aaa/
Email	jsvs@jhf.or.jp

Sponsor
Institute	The Japanese Society for Vascular Surgery
Institute
Department

Funding Source
Organization	The Japanese Society for Vascular Surgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Japanese Committee for Stentgraft Management
Name of secondary funｄer(s)

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	旭川医科大学（北海道）、名古屋大学（愛知県）、東京慈恵会医科大学（東京都）、関西医科大学（大阪府）、弘前大学（青森県）、山口大学（山口県）、信州大学（長野県）、湘南鎌倉総合病院（神奈川県）、森の宮病院（大阪府）、他約100施設

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 15 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.jsvs.org/ja/enquete/aaa/
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is cooperatively managed by Japanese Society of Vascular Surgery and Japanese Committee of Stentgraft Management

Management information
Registered date	2018 Year 01 Month 31 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035491