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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035634
Receipt No. 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 2019/01/23

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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
Middle name
Last name Hiromasa Otake
Organization Kobe University Graduate School of Medicine
Division name Department of Cardiology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 078-382-5846
Email hotake@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Tanimura
Organization Kobe University graduate school of medicine
Division name Department of Cardiology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 078-382-5846
Homepage URL
Email k.tanimura1006@gmail.com

Sponsor
Institute Kobe University graduate school of medicine, Department of Cardiology
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
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
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040282

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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