UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052443 |
|---|---|
| Receipt number | R000059292 |
| Scientific Title | A prospective, open-label, single-centre, randomized study to evaluate coronary microcirculation in de-novo lesions treated with drug-coated balloons or drug-eluting stents |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2023/10/09 12:50:22 |
* 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
A prospective, open-label, single-centre, randomized study to evaluate coronary microcirculation in de-novo lesions treated with drug-coated balloons or drug-eluting stents
Acronym
NEO D5 study
Scientific Title
A prospective, open-label, single-centre, randomized study to evaluate coronary microcirculation in de-novo lesions treated with drug-coated balloons or drug-eluting stents
Scientific Title:Acronym
NEO D5 study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate coronary microcirculation in de-novo lesions treated with drug-coated balloons or drug-eluting stents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The status of the coronary microcirculation before and after treatment and at follow-up angiography
Key secondary outcomes
Indices of Coronary Physiology before and after treatment and at follow-up angiography
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 treatmen
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
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) history of severe valvular heart disease or hypertrophic cardiomyopathy
(5) previous intervention to the same vessel
(6) life expectancy <1 year
(7) inappropriate lesion for assessment of microcirculation (i.e., left main lesions, ostial lesions, heavily calcified lesions, thrombotic lesions)
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
Other
Institute
Department
Personal name
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
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
| 2023 | Year | 10 | 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
| 2023 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 10 | Month | 09 | Day |
Last modified on
| 2023 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059292
