Unique ID issued by UMIN | UMIN000022878 |
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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 |
Safety and efficacy of drug-coated balloon following Excimer laser thrombus evaporation in patients with ST-segment elevation myocardial infarction (Laser-DCB study)
Drug-coated balloon following Excimer laser in patients with acute myocardial infarction
Safety and efficacy of drug-coated balloon following Excimer laser thrombus evaporation in patients with ST-segment elevation myocardial infarction (Laser-DCB study)
Drug-coated balloon following Excimer laser in patients with acute myocardial infarction
Japan |
Acute myocardial infarction (ST-segment elevation myocardial infarction)
Cardiology |
Others
NO
To evaluate the safety and efficacy of drug-coated balloon following Excimer laser thrombus evaporation in patients with acute myocardial infarction.
Safety,Efficacy
Primary procedure succsess rate
Late lumen loss
Restenosis rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
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.
Not applicable |
Not applicable |
Male and Female
Acute myocardial infarction within 24 hours from the onset
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
50
1st name | Yoshihisa |
Middle name | |
Last name | Shimada |
Shiroyama Hospital
Cardiovascular Center
583-0872
2-8-1 Habikino, Habikino-city, Osaka
072-958-1000
shimada@shiroyama-hsp.or.jp
1st name | Daisuke |
Middle name | |
Last name | Tonomura |
Shiroyama Hospital
Cardiovascular Center
583-0872
2-8-1 Habikino, Habikino-city, Osaka
072-958-1000
tonomura@shiroyama-hsp.or.jp
Shiroyama Hospital
none
Self funding
Shiroyama hospital
2-8-1 Habikino, Habikino-city, Osaka, JAPAN
072-958-1000
ishibashi@shiroyama-hsp.or.jp
NO
2016 | Year | 06 | Month | 24 | Day |
https://onlinelibrary.wiley.com/doi/10.1002/ccd.30149
Published
https://pubmed.ncbi.nlm.nih.gov/35253349/
62
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.
2023 | Year | 06 | Month | 28 | Day |
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.
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.
Neither abrupt vessel closure, reinfarction, cardiac death nor major bleeding was observed.
Binary restenosis was observed in five patients (8.1%) in whom target lesion revascularization was performed.
Main results already published
2016 | Year | 06 | Month | 18 | Day |
2016 | Year | 06 | Month | 12 | Day |
2016 | Year | 06 | Month | 24 | Day |
2020 | Year | 04 | Month | 03 | Day |
2016 | Year | 06 | Month | 24 | Day |
2023 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026368
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