UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028615 |
|---|---|
| Receipt number | 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 09:29:06 |
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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
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
h-ueda@takai-hp.com
Sponsor or person
Institute
Koseikai Takai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032726
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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