UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting Stent Trial: Extended Follow-up Study
Title of the study (Brief title)	RESET:Extended Follow-up Study
Region	Japan

Condition
Condition	Coronary Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the long-term efficacy and safety of cobalt chrome everolimus-eluting stent (CoCr-EES) of XIENCE V and 1st generation sirolimus-eluting stent (SES) of Cypher
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Any TLR A composite of all-cause death and MI
Key secondary outcomes

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	3196 patients who participated in the RESET trial.
Key exclusion criteria	Patients who refuse to participate.
Target sample size	3196

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

Public contact
Name of contact person	Hiroki Shiomi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-4255
Homepage URL
Email	hishiomi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Research Institute for Production Development
Institute
Department

Funding Source
Organization	Abbott Vascular
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 05 Day
Anticipated trial start date	2018 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is the extended follow-up study of the RESET randomized study.

Management information
Registered date	2018 Year 01 Month 09 Day
Last modified on	2018 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035094