UMIN-CTR Clinical Trial

Basic information
Public title	Gender difference in long-term clinical outcomes after rotational atherectomy in severely calcified coronary stenoses - from J2T multicenter registry -
Acronym	Gender difference in long-term clinical outcomes after rotational atherectomy - from J2T multicenter registry -
Scientific Title	Gender difference in long-term clinical outcomes after rotational atherectomy in severely calcified coronary stenoses - from J2T multicenter registry -
Scientific Title:Acronym	Gender difference in long-term clinical outcomes after rotational atherectomy - from J2T multicenter registry -
Region	Japan

Condition
Condition	Patients who underwent percutaneous coronary intervention with rotational atherectomy
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine gender differences in long-term clinical prognosis after percutaneous coronary intervention with rotational atherectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Major adverse cardiovascular and cerebrovascular event (any death, acute coronary syndrome, stroke)
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	Patients who underwent percutaneous coronary intervention with rotational atherectomy in Tokyo Women's Medical University, Juntendo University School of Medicine or Teikyo University School of Medicine between January 2004 and December 2015.
Key exclusion criteria	Patients receiving regular hemodialysis
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Nobuhisa Middle name Last name Hagiwara
Organization	Tokyo Women's Medical University
Division name	Department of Cardiology
Zip code	162-8666
Address	8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL	+813-3353-8111
Email	mhagi@hij.twmu.ac.jp

Public contact
Name of contact person	1st name HISAO Middle name Last name OTSUKI
Organization	Tokyo Women's Medical University
Division name	Department of Cardiology
Zip code	162-8666
Address	8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL	+813-3353-8111
Homepage URL
Email	h.otsuki0107@gmail.com

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Women's Medical University
Address	8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
Tel	+813-3353-8111
Email	krinri.bm@twmu.ac.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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	788
Results
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	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB	2016 Year 11 Month 29 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Gender difference was not observed in the long-term MACE in patients following PCI with RA against severe calcified coronary artery stenosis.

Management information
Registered date	2019 Year 10 Month 27 Day
Last modified on	2019 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043752