UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective registry evaluating angiographic and clinical outcomes after treatment with directional coronary atherectomy in patients with ischemic heart disease
Title of the study (Brief title)	DCA registry
Region	Japan

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

Objectives
Narrative objectives1	To assess angiographic and clinical outcomes after treatment with directional coronary atherectomy using intravascular ultrasound in patients with ischemic heart disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Angiographic restenosis at 12 months
Key secondary outcomes	All-cause death, cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization after procedure, at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Success rate of percutaneous coronary intervention. Periprocedural complications including bleeding, coronary perforation, rupture, dissection, spasm, acute occlusion, and shock. Changes in angiographic findings. Changes in lumen area, plaque burden, total atheroma volume, and percent atheroma volume by intravascular ultrasound. Bleeding during follow-up by the BARC bleeding definition, TIMI bleeding criteria, or GUSTO bleeding criteria.

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 with ischemic heart disease undergoing percutaneous coronary intervention with directional coronary atherectomy 2) Patients who have provided written informed consent
Key exclusion criteria	1) Patients who are intolerant to antiplatelet drugs 2) Patients who are intolerant to anticoagulant drugs 3) Patients who are considered inappropriate by the physicians
Target sample size	150

Research contact person
Name of lead principal investigator	Yasunori Nishida
Organization	Koseikai Takai Hospital
Division name	Cardiovascular Medicine
Address	470-8 Kuranosho-cho, Tenri-city, Nara Japan
TEL	0743655552
Email	nishida@takai-hp.com

Public contact
Name of contact person	Hiroshi Ueda
Organization	Koseikai Takai Hospital
Division name	Cardiovascular Medicine
Address	470-8 Kuranosho-cho, Tenri-city, Nara Japan
TEL	0743655552
Homepage URL
Email	h-ueda@takai-hp.com

Sponsor
Institute	Koseikai Takai Hospital
Institute
Department

Funding Source
Organization	Koseikai Takai Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 08 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 05 Month 26 Day
Anticipated trial start date	2017 Year 06 Month 19 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	None

Management information
Registered date	2017 Year 08 Month 09 Day
Last modified on	2017 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032726