UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032513 |
|---|---|
| Receipt number | R000036988 |
| Scientific Title | Prognostic relevance of instantaneous wave-Free Ratio in patients with ischemic heart disease undergoing directional coronary atherectomy followed by a paclitaxel-coated balloon angioplasty |
| Date of disclosure of the study information | 2018/05/09 |
| Last modified on | 2023/05/12 17:12:02 |
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Basic information
Public title
Prognostic relevance of instantaneous wave-Free Ratio in patients with ischemic heart disease undergoing directional coronary atherectomy followed by a paclitaxel-coated balloon angioplasty
Acronym
Prognostic utility of instantaneous wave-Free Ratio in paclitaxel-coated balloon after directional coronary atherectomy
Scientific Title
Prognostic relevance of instantaneous wave-Free Ratio in patients with ischemic heart disease undergoing directional coronary atherectomy followed by a paclitaxel-coated balloon angioplasty
Scientific Title:Acronym
Prognostic utility of instantaneous wave-Free Ratio in paclitaxel-coated balloon after directional coronary atherectomy
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between intravascular ultrasound (IVUS) and instanteneous Wave-Free ratio (iFR) parameters and the mid to long term clinical events in patients with ischemic heart disease undergoing directional coronary atherectomy followed by a drug-coated balloon angioplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Protcol 1, acute phase complications (intravascular ultrasound detected deep cut (either resection of media or adventitia) and/or coronary perforation) and 3 month major adverse cardiac event (MACE) including all-cause death, non-fatal myocardial infarction, clinically driven target lesion revascularization (TLR) defined as any repeat percutaneous coronary intervention or aortocoronary bypass surgery and a diameter stenosis >50% associated with symptoms or objective signs of ischemia (stress electrocardiogram, myocardial perfusion imaging, fractional flow reserve and instantaneous wave-free ratio)
Protcol 2, acute phase complications and 1 year MACE
Protcol 3, acute phase complications and long term MACE (>1 year)
Key secondary outcomes
bailout stenting for flow-limiting dissection, late lumen loss, binary restenosis, follow-up iFR, follow-up focal delta-iFR (treated lesion), procedure time, clinically driven target vessel revascularization
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
instantaneous wave-Free Ratio evaluation in patients undergoing directional coronary atherectomy followed by a drug-coated 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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
directional coronary atherectomy (DCA) target lesion was selected as following criteria;
native coronary artery lesion located in non-ostial left main trunk or right coronary artery, ostium of the left anterior descending or left circumflex artery, or a major bifurcation located at the proximal left anterior descending or left circumflex
symptomatic angina or objective signs of ischemia (stress electrocardiogram, myocardial perfusion imaging, fractional flow reserve, or instantaneous wave-free ratio)
lesion stenosis 50%< and <100%, and 15 mm or less in length by visual estimation
de novo lesion or plain old balloon angioplasty restenotic lesion
vessel suitable for transfemoral approach (DCA device size 7 French or more)
age between 20 and 85-years-old
signed written informed consent
The revascularization (with or without a stent) of distal non-target major vessel lesion in proximity to the target lesion was permitted during the index procedure to achieve iFR-based endpoint (iFR>0.89).
Bailout stenting for target lesion was performed only in cases of a suboptimal result, defined as flow-limiting dissection and/or a persistent residual stenosis refractory to optimal directional coronary atherectomy and balloon dilation. It was reported as "Bailout stenting" separately from the acute phase complications (described below).
(Acute complications were defined as intravascular ultrasound detected deep cut (either resection of media or adventitia) and/or coronary perforation in the target lesion, and adequately treated by watchful waiting, perfusion PTCA, stents, covered-stents, or emergency CABG.)
Key exclusion criteria
culprit lesion for acute myocardial infarction within 2 weeks
Aorto-ostial lesion
presence of thrombus at the lesion
stent or directional coronary atherectomy restenotic lesion
angulated lesion >60 degree
diffuse disease
significant tortuosity
severe peripheral vascular disease
markedly calcified lesion by angiography and/or superficial calcium >180 degree detected by IVUS
attenuated plaque (>180 degree) detected by IVUS
contraindication or intolerance to paclitaxel, aspirin, thienopyridines, or contrast media, and concomitant significant medical condition
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Hagikura |
Organization
Tsukazaki Hospital
Division name
Department of Cardiology
Zip code
6711227
Address
68-1 Waku, Aboshi-ku, Himeji, Hyogo
TEL
+81-79-272-8555
hagikuraarata@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Arata |
| Middle name | |
| Last name | Hagikura |
Organization
Tsukazaki Hospital
Division name
Department of Cardiology
Zip code
6711227
Address
68-1 Waku, Aboshi-ku, Himeji, Hyogo
TEL
+81-79-272-8555
Homepage URL
hagikuraarata@hotmail.co.jp
Sponsor or person
Institute
Department of Cardiology, Tsukazaki 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)
Philips (intravascular ultrasound catheter, This study is NOT receiving any funding.)
IRB Contact (For public release)
Organization
Tsukazaki Hospital
Address
68-1 Waku, Aboshi-ku, Himeji, Hyogo
Tel
+81-79-272-8555
y-fu@tsukazaki-hp.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
| 2018 | Year | 05 | Month | 09 | 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
| 2018 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036988
