UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035634 |
|---|---|
| Receipt number | R000040282 |
| Scientific Title | Prediction of debulking effect of rotational atherectomy by optical frequency domain imaging (OFDI) |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2020/01/24 15:31:25 |
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Basic information
Public title
Prediction of debulking effect of rotational atherectomy by optical frequency domain imaging (OFDI)
Acronym
RA-OFDI registry
Scientific Title
Prediction of debulking effect of rotational atherectomy by optical frequency domain imaging (OFDI)
Scientific Title:Acronym
RA-OFDI registry
Region
| Japan |
Condition
Condition
coronary heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evauate the correlation between the real ablation area and predited ablation area based on optical frequency domain imaging (OFDI) to the patients with severe coronary artery calcification lesions who used Rotational atherectomy during percutaneous coronary angioplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calculation of prediction accuracy (correct and error rate) of Rotational atherectomy based on OFDI images
Key secondary outcomes
1. Percentage of adverse event occurrence (coronary artery perforation, coronary dissection, peri-procedural myocardial infarction, slow-flow / no-reflow phenomenon, rota burr entrapment)
2. Investigation of factors related to prediction accuracy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who scheduled rotational atherectomy for severe coronary artery calcification lesions, those that satisfied the following criteria was registered.
1. Patient who was over 20 years old at the time of PCI.
2. Patient who planed to use rotational atherectomy during PCI.
3. Patients who have severe coronary artery calcification lesions (radiopaque calcified lesions, calcified lesions of more than 180 degrees in OFDI images, or mineralized lesions protruding into the lumen).
4. Patients who can perform intravascular evaluation by OFDI before and after rotational atherectomy.
5. Patients who was able to obtain good analyzable OFDI images.
6. Patients who wrote informed concent by himself/herself.
Key exclusion criteria
1. Patient with acute coronary syndrome.
2. Patient with cardiogenic shock.
3. Patient with in-stent restenosis.
4. Patient with chronic total obstructive lesion.
5. Patient with graft lesion after coronary artery bypass surgery.
6. Patients judged inappropriate by the doctor in charge of this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
6500017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-5846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Tanimura |
Organization
Kobe University graduate school of medicine
Division name
Department of Cardiology
Zip code
6500017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-5846
Homepage URL
k.tanimura1006@gmail.com
Sponsor or person
Institute
Kobe University graduate school of medicine, Department of Cardiology
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
Kobe University Hospital Clinical Translational Research Center
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
Tel
078-382-6669
chiken@med.kobe-u.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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study was to evaluate the prediction accuracy (correct and error rate) obtained by OFDI images before and after rotary atherectomy during PCI for patients with severe coronary artery calcification lesions, and to investigate the factor related to relevance and prediction between accuracy and occurrence of complications.
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040282
