UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Inoue Stentraft Implantation for Aortic Aneurysm and Dissectioin
Title of the study (Brief title)	Inoue Stentraft Implantation
Region	Japan

Condition
Condition	Aortic Aneurysm and Aortic Dissection
Classification by specialty	Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the long term clinical outcome of Inoue stentgraft for aortic aneurysm and dissection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	technical success, perioperative mortality, incidence of complication
Key secondary outcomes	Event free survival of total death, aneurysm related death,second intervention and surgical conversion.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	perform stentgraft implantation
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	The patient of aortic aneurysm and dissection. Surgical treatment is high risk because of complicating disorder. The morphology of aneurysm and dissection is appropriate for stentgraft implantation.
Key exclusion criteria	The morphology of aneurysm and dissection is not appropriate for stentgraft implantation because of the occlusion, calcification and meandering of artery. The massive atheroma or thrombi at the landing zone of stentgraft. Pregnant or breast feeding female Uncontrollable blood-clotting disorder Systemic infection
Target sample size	100

Research contact person
Name of lead principal investigator	Takeshi Kimura
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Cardiovascular Medicine
Address	54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-4255
Email	taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Junichi Tazaki
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Cardiovascular Medicine
Address	54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-4255
Homepage URL
Email	jun1@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	PTMC institute
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	PTMC institute
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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 03 Month 18 Day
Anticipated trial start date	2011 Year 04 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	https://www.ncbi.nlm.nih.gov/pubmed/28583734
Publication of results	Partially published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28583734
Results	All deployments of branched ISGs were successful. The 30-day mortality was 4.5% (single branch, 3.1%; double branch, 0%; triple branch, 29%), and periprocedural stroke was 16% (single branch, 7.8%; double branch, 33%; triple branch, 42%). At 1 and 5 years, freedom from aneurysm-related death was 93% and 93%, respectively, and freedom from all-cause death was 85% and 59%, respectively. Survival free of major adverse events was 76% at 5 years. The cumulative incidence of stroke was 11% at 5 years. Three patients underwent surgical conversion because of persistent type I endoleak. One branch graft occlusion was observed at the left subclavian artery in a patient who received a double-branched graft.
Other related information

Management information
Registered date	2011 Year 04 Month 13 Day
Last modified on	2017 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006443