UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047231 |
|---|---|
| Receipt number | R000053796 |
| Scientific Title | Comparison of the Incidence of Slow Flow Following Rotational Atherectomy to Severely Calcified Coronary Artery Lesions between Short Single Session Versus Long Single Session: A Randomized Controlled Trial. |
| Date of disclosure of the study information | 2022/03/25 |
| Last modified on | 2025/03/12 16:10:04 |
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Basic information
Public title
Comparison of the Incidence of Slow Flow Following Rotational Atherectomy to Severely Calcified Coronary Artery Lesions between Short Single Session Versus Long Single Session: A Randomized Controlled Trial.
Acronym
Comparison of the Incidence of Slow Flow Following Rotational Atherectomy to Severely Calcified Coronary Artery Lesions between Short Single Session Versus Long Single Session: A Randomized Controlled Trial.
Scientific Title
Comparison of the Incidence of Slow Flow Following Rotational Atherectomy to Severely Calcified Coronary Artery Lesions between Short Single Session Versus Long Single Session: A Randomized Controlled Trial.
Scientific Title:Acronym
ROTASOLO trial
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that short single session (no more than 15 seconds) can reduce the incidence of slow flow following rotational atherectomy to severely calcified coronary lesions as compared to long single session (20-30 seconds).
The purpose of this study is to compare the incidence of slow flow following rotational atherectomy to severely calcified coronary artery lesions between short single session versus long single session.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Slow flow just following rotational atherectomy.
Slow flow is defined as [(initial TIMI-frame count)x1.1 minus (TIMI frame count just after rotational atherectomy) ] less than 0.
Absence of slow flow is defined as [(initial TIMI-frame count)x1.1 minus (TIMI frame count just after rotational atherectomy) ] not lower than 0.
If >/=2 burrs are used for rotational atherectomy, slow flow will be evaluated only after the initial burr cross the lesion. Once initial burr crosses the lesion, slow flow will not be evaluated for this study after the second burr cross the lesion.
If initial burr cannot cross the lesion and the second burr (typically smaller burr) cross the lesion, slow flow will be evaluated for this study after the second burr cross the lesion.
If halfway rotational atherectomy is performed, slow flow will be evaluated just after halfway rotational atherectomy.
Key secondary outcomes
Periprocedural myocardial infarction. Complications such as vessel perforation.
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
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
short single session (up to 15 seconds)
Interventions/Control_2
long single session (20 to 30 seconds)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with ischemic heart disease who undergo percutaneous coronary intervention using rotational atherectomy.
2. Patients who gave written informed consent.
3. Angiographically severe calcification in target lesions.
4. Intravascular imaging shows over 180 degree superficial calcification/calcified nodule, intravascular imaging devices cannot cross the lesion due to severe stenosis, or intravascular imaging device (typically optical coherent tomography) cannot provide valid images due to severe stenosis.
Key exclusion criteria
1. Less than 20 years-old.
2. Contraindication in instructions-for-use of Rotablator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Sakakura |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
330-8503
Address
1-847 Amanuma, Omiya, Saitama City
TEL
048-647-2111
ksakakura@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Sakakura |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
330-8503
Address
1-847 Amanuma, Omiya, Saitama City
TEL
048-647-2111
Homepage URL
ksakakura@jichi.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Saitama Medical Center, Jichi Medical University
Address
1-847 Amanuma, Omiya, Saitama City
Tel
048-647-2111
s-suishin@jichi.ac.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
実施確定施設（IRB承認済）：自治医科大学附属さいたま医療センター（埼玉県）、練馬光が丘病院（東京都）、JCHO埼玉メディカルセンター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 25 | 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
| 2022 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 03 | Month | 12 | Day |
Date analysis concluded
Other
Other related information
The inclusion is smoothly progressed (20 Sep 2023).
The inclusion is smoothly progressed (21 Mar 2024).
The inclusion is smoothly progressed (20 Sep 2024).
Since the inclusion was completed 19 Feb 2025, no longer recruiting (20 Feb 2025).
Management information
Registered date
| 2022 | Year | 03 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053796
