UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022878
Receipt number R000026368
Scientific Title Safety and efficacy of drug-coated balloon following Excimer laser thrombus evaporation in patients with ST-segment elevation myocardial infarction (Laser-DCB study)
Date of disclosure of the study information 2016/06/24
Last modified on 2023/06/28 15:09:24

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Basic information

Public title

Safety and efficacy of drug-coated balloon following Excimer laser thrombus evaporation in patients with ST-segment elevation myocardial infarction (Laser-DCB study)

Acronym

Drug-coated balloon following Excimer laser in patients with acute myocardial infarction

Scientific Title

Safety and efficacy of drug-coated balloon following Excimer laser thrombus evaporation in patients with ST-segment elevation myocardial infarction (Laser-DCB study)

Scientific Title:Acronym

Drug-coated balloon following Excimer laser in patients with acute myocardial infarction

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 safety and efficacy of drug-coated balloon following Excimer laser thrombus evaporation 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

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Excimer laser thrombus evaporation is performed after initial treatment of conventional manual thrombectomy. Drug-coated balloon is used following balloon angioplasty for the culprit lesion.

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

Acute 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
7) No indication for percutaneous coronary intervention
8) Other conditions judged inappr opriate by the attending physician

Target sample size

50


Research contact person

Name of lead principal investigator

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

Email

shimada@shiroyama-hsp.or.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Tonomura

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

tonomura@shiroyama-hsp.or.jp


Sponsor or person

Institute

Shiroyama 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)



IRB Contact (For public release)

Organization

Shiroyama hospital

Address

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

Tel

072-958-1000

Email

ishibashi@shiroyama-hsp.or.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

2016 Year 06 Month 24 Day


Related information

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1002/ccd.30149

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35253349/

Number of participants that the trial has enrolled

62

Results

Scheduled angiography at 8 months and 2 years was completed in 100% and 85.2%, respectively, and minimal lumen diameters were 3.4, 3.4, and 3.4 mm after the procedure, at 8 months and at 2 years, respectively. Binary restenosis was observed in five patients (8.1%) in whom target lesion revascularization was performed. Neither abrupt vessel closure, reinfarction, cardiac death nor major bleeding was observed.

Results date posted

2023 Year 06 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Age 63years old, male 87%, hypertension 82%, diabetes mellitus 39%, dyslipidaemia 82%, current smoker 40%. Symptom onset to hospital arival was 3.9 hours on average.

Participant flow

From June 2016 to February 2018, 120 consecutive patients with STEMI who presented within 24 h after the onset of symptoms un- derwent emergent PCI at our hospital. Patients with the following conditions were excluded from this study: cardiogenic shock or he- modynamic instability (n = 16); impaired kidney function (serum creatinine level > 2.0mg/dl; n=10); small vessel disease (<2mm in diameter; n = 6); STEMI caused by left main occlusion (n = 4), embo- lism from atrial fibrillation (n=5) or spontaneous coronary artery dissection (n = 1); frailty (n = 8), and other conditions that the physi- cians considered inappropriate (n = 8). Therefore, a total of 62 lesions in 62 patients were targeted to undergo ELCA followed by DCB angioplasty of the infarct!related artery and included in this study.

Adverse events

Neither abrupt vessel closure, reinfarction, cardiac death nor major bleeding was observed.

Outcome measures

Binary restenosis was observed in five patients (8.1%) in whom target lesion revascularization was performed.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 06 Month 18 Day

Date of IRB

2016 Year 06 Month 12 Day

Anticipated trial start date

2016 Year 06 Month 24 Day

Last follow-up date

2020 Year 04 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 24 Day

Last modified on

2023 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026368


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name