UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051470 |
|---|---|
| Receipt number | R000058644 |
| Scientific Title | Rotational atherectomy and Wolverine cutting balloon angioplasty prior to Agent drug-coated balloon application in calcified coronary lesions |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/07/12 15:47:00 |
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Basic information
Public title
Rotational atherectomy and Wolverine cutting balloon angioplasty prior to Agent drug-coated balloon application in calcified coronary lesions
Acronym
Rotaverigent study
Scientific Title
Rotational atherectomy and Wolverine cutting balloon angioplasty prior to Agent drug-coated balloon application in calcified coronary lesions
Scientific Title:Acronym
Rotaverigent study
Region
| Japan |
Condition
Condition
Coronary atherosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of Agent drug-coated balloon following combined high-speed rotational atherectomy and Wolverine cutting balloon angioplasty in calcified coronary lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary patency (free ratio from target lesion revascularization)
Key secondary outcomes
1) late lumen loss assesed by follow-up angiography
2) lale luminal area loss assesed by follow-up intravascular ultrasound examination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Combined lesion preparation using rotational atherectomy and consecutive cutting balloon angioplasty, followed by drug-coated balloon application in calcified coronary lesions.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Moderate to severe calcified coronary stenotic lesions
Key exclusion criteria
1) Cardiogenic shock or hemodynamic instability
2) Myocardial infarction within 7 days
3) Reference vessel diameter < 2.0 mm
4) In-stent restenoses
5) Women of childbearing potential
6) Other conditions judged inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Shimada |
Organization
Shiroyama hospital
Division name
Cardiovascular center
Zip code
583-0872
Address
2-8-1 Habikino, Habikino-city, Osaka
TEL
+81-72-958-1000
shimada@shiroyama-hsp.or.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Terashita |
Organization
Shiroyama hospital
Division name
Cardiovascular center
Zip code
583-0872
Address
2-8-1 Habikino, Habikino-city, Osaka
TEL
+81-72-958-1000
Homepage URL
k-terashita@shiroyama-hsp.or.jp
Sponsor or person
Institute
Shiroyama hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
the Ethics Committee of Shiroyama hospital
Address
2-8-1 Habikino, Habikino-city, Osaka
Tel
+81-72-958-1000
kishimoto@shiroyama-hsp.or.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 | 07 | Month | 01 | 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 | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | 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 | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058644
