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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031525
Receipt No. R000036001
Scientific Title Feasibility and efficacy of drug-coated balloon angioplasty following excimer laser thrombus vaporization in patients with acute myocardial infarction: multicenter study
Date of disclosure of the study information 2018/03/01
Last modified on 2018/03/01

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Basic information
Public title Feasibility and efficacy of drug-coated balloon angioplasty following excimer laser thrombus vaporization in patients with acute myocardial infarction: multicenter study
Acronym Drug-coated balloon angioplasty following excimer laser in patients with acute myocardial infarction: multicenter study
Scientific Title Feasibility and efficacy of drug-coated balloon angioplasty following excimer laser thrombus vaporization in patients with acute myocardial infarction: multicenter study
Scientific Title:Acronym Drug-coated balloon angioplasty following excimer laser in patients with acute myocardial infarction: multicenter study
Region
Japan

Condition
Condition Acute myocardial infarction (ST-segment elevation myocardial infarction)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility and efficacy of drug-coated balloon angioplasty following excimer laser thrombus vaporization and scoring balloon angioplasty in patients with acute myocardial infarction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary procedure succsess rate
Late lumen loss
Restenosis rate
Major adverse cardiac events
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ST-segment elevation myocardial infarction within 24 hours from the onset
Key exclusion criteria 1) Cardiac arrest or post-resuscitation
2) Cardiogenic shock or hemodynamic instability
3) Serum creatinine 2.0 mg/dl or above
4) Significant congestive heart failure
5) Left main trunk disease
6) Reference vessel diameter < 2.0 mm by visual estimate
7) No indication for percutaneous coronary intervention
8) Other conditions judged inappropriate by the attending physician
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Kataoka
Organization Bell-Land General Hospital
Division name Cardiovascular Medicine
Zip code
Address 500-3 Higashiyama, Naka-ku, Sakai-city, Osaka
TEL 072-234-2001
Email t_kataoka@seichokai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Shimada
Organization Shiroyama Hospital
Division name Cardiovascular Center
Zip code
Address 2-8-1 Habikino, Habikino-city, Osaka
TEL 072-958-1000
Homepage URL
Email shimada@shiroyama-hsp.or.jp

Sponsor
Institute Bell-Land General Hospital
Shiroyama Hospital
Institute
Department

Funding Source
Organization Bell-Land General Hospital
Shiroyama Hospital
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2018 Year 03 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2018 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 Prospective study

Management information
Registered date
2018 Year 03 Month 01 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036001

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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