UMIN-CTR Clinical Trial

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
Email	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
Email	f.saito@tokai-u.jp

Sponsor
Institute	Tokai University
Institute
Department

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
Email	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

Management information
Registered date	2018 Year 06 Month 12 Day
Last modified on	2022 Year 06 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036828

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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