UMIN-CTR Clinical Trial

Basic information
Public title	Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
Acronym	Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
Scientific Title	Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
Scientific Title:Acronym	Risk factors for stent failure after drug-eluting stent implantation for calcified nodule: An optical coherence tomography study
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate the risk factor for stent failure after drug-eluting stent implantation for calcified nodule.
Basic objectives2	Others
Basic objectives -Others	investigation of risk factor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Target lesion revascularization
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	(1) patients who underwent OCT-guided PCI from August 2013 to October 2020 (2)patients whose culprit lesion had CN detected by pre PCI OCT
Key exclusion criteria	(1)patients who were not implanted drug-eluting stents (DES) (those treated with drug-coated balloon [DCB], and those treated with percutaneous old balloon angioplasty [POBA] or rotation atherectomy [RA] alone) (2)those with in-stent restenosis (3)those with coronary artery bypass grafted lesions (4)those with insufficient OCT data quality (5)those who died within a year after the index PCI
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Hiromasa Middle name Last name Otake
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL	0783825846
Email	hotake@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Tomoyo Middle name Last name Hamana
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL	0783825846
Homepage URL
Email	tomohamachi@yahoo.co.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Kobe University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kobe university hospital clinical and translational research center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel	0783826669
Email	ccrspprt@med.kobe-u.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	2022 Year 08 Month 01 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	120
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	No longer recruiting
Date of protocol fixation	2022 Year 07 Month 27 Day
Date of IRB	2022 Year 09 Month 12 Day
Anticipated trial start date	2022 Year 09 Month 12 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	Multicenter, retrospective, observational study

Management information
Registered date	2022 Year 07 Month 27 Day
Last modified on	2022 Year 07 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055258