UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023017 |
|---|---|
| Receipt number | R000026512 |
| Scientific Title | Safety and efficacy of drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions |
| Date of disclosure of the study information | 2016/07/04 |
| Last modified on | 2023/06/28 15:50:29 |
* 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
Safety and efficacy of drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions
Acronym
RotaCut-Sequent study
Scientific Title
Safety and efficacy of drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions
Scientific Title:Acronym
RotaCut-Sequent study
Region
| Japan |
Condition
Condition
calcified coronary stenotic lesions
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of drug-coated balloon following high-speed rotational atherectomy in patients with calcified coronary stenoses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary procedure success rate
Late lumen loss
Restenosis rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
High-speed rotational atherectomy is performed using Rotablator for calcified coronary lesions. Subsequently, drug-coated balloon is used following balloon angioplasty.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Moderate to severe calcified coronary stenotic lesions
Key exclusion criteria
1) Myocardial infarction within 7 days
2) Cardiogenic shock or hemodynamic instability
3) Unprotected left main lesions
4) In-stent restenoses
5) Reference vessel diameter < 2.0 mm
6) No indication for percutaneous coronary intervention
7) Other conditions judged inappropriate by the attending physician
Target sample size
50
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
072-958-1000
shimada@shiroyama-hsp.or.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Kino |
Organization
Shiroyama Hospital
Division name
Cardiovascular Center
Zip code
583-0872
Address
2-8-1 Habikino, Habikino-city, Osaka
TEL
072-958-1000
Homepage URL
kino@shiroyama-hsp.or.jp
Sponsor or person
Institute
Shiroyama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Shiroyama hospital
Address
2-8-1 Habikino, Habikino-city, Osaka
Tel
072-958-1000
shimada@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
| 2016 | Year | 07 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026512
