UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032954 |
|---|---|
| Receipt number | R000036828 |
| Scientific Title | Laser Atherectomy for ST elevation myocardial infarction |
| Date of disclosure of the study information | 2018/06/12 |
| Last modified on | 2024/06/16 14:12:08 |
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Basic information
Public title
Laser Atherectomy for ST elevation myocardial infarction
Acronym
LASTPASS
Scientific Title
Laser Atherectomy for ST elevation myocardial infarction
Scientific Title:Acronym
LASTPASS
Region
| Japan |
Condition
Condition
ST-elevation acute myocardial infarction (STEMI)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness of excimer laser coronary angiplasty (ELCA) on myocardial salvage in patients with anterior STEMI evaluated by nuclear scintigraphy (BMIPP 3-9 days after p-PCI and Tc99m-tetrofosmin at 6 months after p-PCI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
myocardial salvage = (Risk at area measured by BMIPP 3-9 days after p-PCI) - (Infarct size measured by Tc99m-tetrofosmin at 6 months after p-PCI)
myocardial salvage index (%) = myocardial salvage / Risk at area measured by BMIPP 3-9 days after p-PCI x 100
Key secondary outcomes
Myocardial salvage, infarct size, microvascular obstruction by MRI
Left ventricular ejection fraction by TF scintigraphy at 6 months
12 months, 36 months, 60 months Clinical end point
Intra-stent tissue volume by OCT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Excimer laser catheter
Interventions/Control_2
Standard treatment
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients to whom PCI treatment for Anterior STEMI is indicated
[Main selection criteria]
First-episode Anterior STEMI patients within 6 hours of onset that satisfy electrocardiogram criteria
Patients who are 21 years of age or older at the time of consent acquisition
Patient who the patient himself agreed in writing
Key exclusion criteria
Patients presenting cardiac shock at the time of visit
Patients whose target lesions are left main trunk, circumflex, right coronary artery, distal anterior descending branch
Patients who have TIMI 2, 3 at the initial imaging
Patients with a reference vessel diameter of 2.5 mm or less
Patients determined to lack consent ability for mental or other reasons
Patient who is judged inappropriate by research researcher or research sharing doctor
Target sample size
248
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Ikari |
Organization
Tokai University
Division name
Department of Cardiovascular Medicine
Zip code
259-1193
Address
Kanagawa prefecture Isehara-shi Shimosya store 143
TEL
0463-93-1121
ikari@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Fumie |
| Middle name | |
| Last name | Saito |
Organization
Tokai University
Division name
Department of Cardiovascular Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, 259-1193 Japan
TEL
0463-93-1121
Homepage URL
f.saito@tokai-u.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Shinjukuku, Tokyo
Tel
03-5363-3961
crc-admin@ctr.hosp.keio.ac.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
| 2018 | Year | 06 | Month | 12 | 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
100
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 | 06 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The first report was accepted for a late-breaking trial at EuroPCR 2024 in May,2024.
Management information
Registered date
| 2018 | Year | 06 | Month | 12 | Day |
Last modified on
| 2024 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036828
