UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032152 |
|---|---|
| Receipt number | 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 | 2023/09/19 15:38:08 |
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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
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
riverclose0604@yahoo.co.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka Heart Club
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
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
https://eurointervention.pcronline.com/article/coronary-vasomotion-after-treatment-with-drug-coated-
Publication of results
Published
Result
URL related to results and publications
https://eurointervention.pcronline.com/article/coronary-vasomotion-after-treatment-with-drug-coated-
Number of participants that the trial has enrolled
46
Results
The luminal dimension in the treated segment did not differ between groups at the follow-up angiography. The vasoconstriction after acetylcholine infusion was less pronounced in the DCB arm than in the DES arm. The response to nitroglycerine did not differ between groups, suggesting that endothelial function in treated coronary vessels could be better preserved by DCB than by new-generation DES.
Results date posted
| 2023 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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.
Participant flow
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. In the drug-eluting stent arm, stent implantation was performed in standard practice. Post-dilation was left to the operator's discretion.
All patients were scheduled to undergo clinical and angiographic follow-up at 8 months. Endothelial function was evaluated by acetylcholine (ACh) vasomotion test at follow-up angiography
Adverse events
None
Outcome measures
The primary endpoint of this study was endothelial function adjacent to the treated segment by vasomotion test at follow-up angiography. Secondary endpoints included angiographic measurements, intravascular ultrasound (IVUS) parameters, and clinical outcomes according to the Academic Research Consortium criteria.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036678
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