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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028615
Receipt No. R000032726
Scientific Title A prospective registry evaluating angiographic and clinical outcomes after treatment with directional coronary atherectomy in patients with ischemic heart disease
Date of disclosure of the study information 2017/08/10
Last modified on 2017/08/09

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Basic information
Public title A prospective registry evaluating angiographic and clinical outcomes after treatment with directional coronary atherectomy in patients with ischemic heart disease
Acronym DCA registry
Scientific Title A prospective registry evaluating angiographic and clinical outcomes after treatment with directional coronary atherectomy in patients with ischemic heart disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasunori Nishida
Organization Koseikai Takai Hospital
Division name Cardiovascular Medicine
Zip code
Address 470-8 Kuranosho-cho, Tenri-city, Nara Japan
TEL 0743655552
Email nishida@takai-hp.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Ueda
Organization Koseikai Takai Hospital
Division name Cardiovascular Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 26 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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