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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032152
Receipt No. R000036678
Scientific Title The degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to drug-eluting stent
Date of disclosure of the study information 2018/04/09
Last modified on 2019/04/09

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Basic information
Public title The degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to drug-eluting stent
Acronym The degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to drug-eluting stent (D5 study)
Scientific Title The degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to drug-eluting stent
Scientific Title:Acronym The degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to drug-eluting stent (D5 study)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to a drug-eluting stent
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The coronary vasoreactivity (the change in luminal diameter of beginning 5 mm and ending 15 mm distal to the end of the treated segment) in response to acetylcholine infusion into the coronary artery at follow-up angiography
Key secondary outcomes Restenosis and late lumen loss at follow-up angiography
Major adverse cardiac events (all-cause death, myocardial infarction and target lesion revascularization)
Canadian Cardiovascular Society grading of angina pectoris after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 All lesions were pre-dilated using a regular balloon. If a good angiographic result was obtained, patients were randomly assigned to one of the treatment strategies with drug-coated balloon and drug-eluting stent.
In the drug-coated balloon arm, the lesion was followed by only once dilation with drug-coated balloon.
Interventions/Control_2 All lesions were pre-dilated using a regular balloon. If a good angiographic result was obtained, patients were randomly assigned to one of the treatment strategies with drug-coated balloon and drug-eluting stent.
In the drug-eluting stent arm, stent implantation was performed in standard practice. Post-dilation was left to the operator's discretion.
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 Patients with stable or unstable angina or documented silent ischemia with de novo coronary lesions scheduled to undergo PCI. The inclusion criteria were lesions with a reference vessel diameter between 2.0mm-3.0mm and a lesion length of = or <25mm.
Key exclusion criteria (1) left ventricular ejection fraction <30%
(2) known renal failure (creatinine >2mg/dl)
(3) acute myocardial infarction within the previous 48 hours
(4) known hypersensitivity or contraindication to the required medication
(5) history of vasospastic angina
(6) life expectancy <1 year
(7) previous intervention to the same vessel
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tsutomu
Middle name
Last name Kawai
Organization Osaka General Medical Center
Division name Division of cardiology
Zip code 558-8558
Address 3-1-56, Bandaihigashi, Sumiyoshi, Osaka
TEL 06-6692-1201
Email riverclose0604@yahoo.co.jp

Public contact
Name of contact person
1st name Tsutomu
Middle name
Last name Kawai
Organization Osaka General Medical Center
Division name Division of cardiology
Zip code 558-8558
Address 3-1-56, Bandaihigashi, Sumiyoshi, Osaka
TEL 06-6692-1201
Homepage URL
Email riverclose0604@yahoo.co.jp

Sponsor
Institute Osaka General Medical Center
Institute
Department

Funding Source
Organization None
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 Osaka General Medical Center
Address 3-1-56, Bandaihigashi, Sumiyoshi, Osaka
Tel 0666921201
Email riverclose0604@yahoo.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
2018 Year 04 Month 09 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
2018 Year 01 Month 29 Day
Date of IRB
2018 Year 03 Month 07 Day
Anticipated trial start date
2018 Year 04 Month 09 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 08 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036678

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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