UMIN-CTR Clinical Trial

Basic information
Public title	Stent less percutaneous coronary intervention with imaging technology
Acronym	SWITCH trial
Scientific Title	Stent less percutaneous coronary intervention with imaging technology
Scientific Title:Acronym	SWITCH trial
Region	Japan

Condition
Condition	coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to evaluate the acute and chronic results of drug coated balloon with imaging device for de novo small vessel lesions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate and predictor of late lumen enlargement by intravascular imaging devices
Key secondary outcomes

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	Maneuver
Interventions/Control_1	PCI with drug coated balloon
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	20 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	small vessel (less than 3 mm) patients who have DAPT at least 1 month patients who agree with follow-up CAG and follow-up imaging data at 8 month after PCI
Key exclusion criteria	LMT or SVG large vessel more than 3mm distal reference more than 2.75mm and we can implant 3mm stent ISR side branch ostium or side branch jailed by stents STEMI or NSTEMI patients who have active bleeding patients who participate in the other interventional studies life expectancy of less than 1year dementia
Target sample size	100

Research contact person
Name of lead principal investigator	1st name masami Middle name Last name nishino
Organization	Osaka Rosai Hospital
Division name	cardiology
Zip code	591-8025
Address	3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL	072-252-3561
Email	mnishino@osakah.johas.go.jp

Public contact
Name of contact person	1st name yutaka Middle name Last name matsuhiro
Organization	osaka rosai hospital
Division name	cardiology
Zip code	591-8025
Address	3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL	072-252-3561
Homepage URL
Email	junnai-hisho@osakah.johas.go.jp

Sponsor
Institute	Osaka Rosai Hospital
Institute
Department

Funding Source
Organization	none
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	osaka rosai hospital
Address	3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
Tel	072-252-3561
Email	junnai-hisho@osakah.johas.go.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	2021 Year 01 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
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	Preinitiation
Date of protocol fixation	2021 Year 01 Month 04 Day
Date of IRB	2021 Year 01 Month 25 Day
Anticipated trial start date	2021 Year 01 Month 29 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 28 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049267