UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031525
Receipt number R000036001
Scientific Title Laser photoablation and NSE scoring balloon angioplasty before drug-coated balloon application in ST-segment elevation myocardial infarction: the L'Anse-DCB study
Date of disclosure of the study information 2018/03/01
Last modified on 2023/08/15 12:38:59

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Basic information

Public title

Laser photoablation and NSE scoring balloon angioplasty before drug-coated balloon application in ST-segment elevation myocardial infarction: the L'Anse-DCB study

Acronym

Drug-coated balloon angioplasty following excimer laser in patients with acute myocardial infarction: multicenter study

Scientific Title

Laser photoablation and NSE scoring balloon angioplasty before drug-coated balloon application in ST-segment elevation myocardial infarction: the L'Anse-DCB 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 Toru
Middle name
Last name Kataoka

Organization

Bell-Land General Hospital

Division name

Cardiovascular Medicine

Zip code

599-8247

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 Yoshihisa
Middle name
Last name Shimada

Organization

Shiroyama Hospital

Division name

Cardiovascular Center

Zip code

583-0872

Address

2-8-1 Habikino, Habikino-city, Osaka

TEL

072-958-1000

Homepage URL


Email

shimada@shiroyama-hsp.or.jp


Sponsor or person

Institute

Bell-Land General Hospital
Shiroyama Hospital

Institute

Department

Personal name



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

The Ethics Committee of Bellland General Hospital

Address

500-3 Higashiyama, Naka-ku, Sakai-city, Osaka

Tel

072-234-2001

Email

t.igu74@gmail.com


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

No longer recruiting

Date of protocol fixation

2018 Year 02 Month 16 Day

Date of IRB

2018 Year 02 Month 21 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2023 Year 07 Month 01 Day

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

2023 Year 08 Month 15 Day



Link to view the page

Value
https://center6.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