UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041784
Receipt No. R000047607
Scientific Title The investigation of cardiovascular prognosis and vascular reaction after directional coronary atherectomy followed by drug-coated balloon angioplasty
Date of disclosure of the study information 2020/09/14
Last modified on 2020/09/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The investigation of optimal cardiovascular treatment with directional coronary atherectomy
Acronym OPT-DCA
Scientific Title The investigation of cardiovascular prognosis and vascular reaction after directional coronary atherectomy followed by drug-coated balloon angioplasty
Scientific Title:Acronym OPT-DCA
Region
Japan

Condition
Condition Coronary atherosclerosis
Angina pectoris, Acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To assess cardiovascular prognosis in patients who underwent PCI with DCA.
2) To evaluate effects of the treatment combined DCA with DCB.
Basic objectives2 Others
Basic objectives -Others The investigation of the independent predictor of cardiovascular events after PCI combined DCA and DCB.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1) Composite endpoint; Cardiac death, non-fatal myocardial infarction, Revascularization for target lesion or vessel failure.
2) The difference between DCA+DCB therapy and DCA alone therapy.
Key secondary outcomes The assessment for risk factor of adverse prognosis in DCA+DCB therapy.

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients more than 20 years old, at the timing of percutaneous coronary intervention (PCI).

2) Patients who was performed PCI with directional coronary atherectomy.
Key exclusion criteria 1) Patients with any malignancy or inflammatory diseases (such as rheumatoid and connective tissue disease)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Yamamoto
Organization Hyogo Brain and Heart Center
Division name The division of Cardiovascular medicine
Zip code 670-0981
Address 520, Saisho-Kou
TEL +81792933131
Email y0493589m@hotmail.co.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Yamamoto
Organization Hyogo Brain and Heart Center
Division name The division of Cardiovascular medicine
Zip code 670-0981
Address 520, Saisho-Kou, Himeji, Japan
TEL +81792933131
Homepage URL
Email y0493589m@hotmail.co.jp

Sponsor
Institute Hyogo Brain and Heart Center
Institute
Department

Funding Source
Organization Hyogo Brain and Heart Center
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 Hyogo Brain and Heart Centor
Address 520, Saisyo-Kou, Himeji, Hyogo, Japan
Tel 0792933131
Email y0493589m@hotmail.co.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
2020 Year 09 Month 14 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
2020 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 23 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing.

Management information
Registered date
2020 Year 09 Month 14 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.