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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032520
Receipt No. R000037087
Scientific Title instantaneous wave-Free Ratio based decision making 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 2018/11/15

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Basic information
Public title instantaneous wave-Free Ratio based decision making in patients with ischemic heart disease undergoing directional coronary atherectomy followed by a paclitaxel-coated balloon angioplasty
Acronym instantaneous wave-Free Ratio based decision making in patients undergoing paclitaxel-coated balloon angioplasty after directional coronary atherectomy
Scientific Title instantaneous wave-Free Ratio based decision making in patients with ischemic heart disease undergoing directional coronary atherectomy followed by a paclitaxel-coated balloon angioplasty
Scientific Title:Acronym instantaneous wave-Free Ratio based decision making in patients undergoing paclitaxel-coated balloon angioplasty 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 whether instanteneous wave-Free Ratio (iFR) based decision making is useful for the prevention of acute phase complication and the prediction of 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 Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 iFR-based decision making group, (predicted post PCI iFR > 0.89)
Interventions/Control_2 control group, IVUS based decision (visually estimated percent plaque area <50%)
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 75%< 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) in iFR group, or treat IVUS detected severe stenosis (minimum lumen diameter<2.0mm, minimum lumen area<4.0 square millimeter) in control group.

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 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Arata Hagikura
Organization Tsukazaki Hospital
Division name Department of Cardiology
Zip code
Address 68-1 Waku, Aboshi-ku, Himeji, Hyogo
TEL +81-79-272-8555
Email hagikuraarata@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Arata Hagikura
Organization Tsukazaki Hospital
Division name Department of Cardiology
Zip code
Address 68-1 Waku, Aboshi-ku, Himeji, Hyogo
TEL +81-79-272-8555
Homepage URL
Email hagikuraarata@hotmail.co.jp

Sponsor
Institute Tsukazaki Hospital
Institute
Department

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
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

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 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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

Management information
Registered date
2018 Year 05 Month 08 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037087

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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