STEMI - ST Elevation Myocardial InfarctionNCT03950310

Laser Atherectomy for ST Elevation Myocardial Infarction

A study testing Excimer laser catheter in people with STEMI - ST Elevation Myocardial Infarction, run by Tokai University at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: STEMI - ST Elevation Myocardial Infarction
What is being tested?: Excimer laser catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteJapan
Study dates: 26 Jul 2018to 31 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

The inclusion and exclusion criteria for the MRI will follow the main study, but in addition, will exclude following conditions.
Atrial fibrillation subject at the timing of MRI scan
Internally implanted devices such as pacemakers or ICDs
Subject that is allergic to Gadolinium,
Subject with claustrophobia
Pregnancy

Trial locations and contacts

1 site in 1 country.

Japan1 site

Tokai University School of Medicine
Isehara, Kanagawa, 259-1193

Other trials in Japan

About this study

Official title: Evaluation of Myocardial Salvage by Scintigraphy After Excimer Laser Coronary Angioplasty and Percutaneous Coronary Intervention With Biodegradable-polymer Platinum Chromium Everolimus-eluting Stent in the Patients With Anterior ST Elevation Myocardial Infarction

The objectives of this study are to observe and examine prospectively whether excimer laser coronary angioplasty (ELCA) and percutaneous coronary intervention with biodegradable-polymer platinum chromium everolimus-eluting stent may improve the myocardial salvage in the patients with anterior ST elevation myocardial infarction (STEMI) using the myocardial scintigram (acute-phase I123-BMIPP and chronic-phase 99mTc-tetrofosmin), and to clarify the myocardial protective effect of excimer laser in the patients with anterior STEMI.

Read the detailed description

The clinical result of catheter treatment in the patients with acute myocardial infarction in these several decades improved because of progress of early reperfusion therapy and stent treatment technique. However, the no-reflow phenomenon is still remaining as a problem, which is involved in a decrease in left ventricular function and worsening of prognosis. It is considered that the no-reflow phenomenon is induced by atherosclerotic and thrombotic emboli, endothelial dysfunction of capillary vessels, free radicals and cytokine. The treatment combining the peripheral protection and thrombus aspiration aiming at prevention of no-reflow is expected to reduce no-reflow and the infarct size and has been conducted on the patients with acute myocardial infarction. However, a lot of randomized studies have been conducted, so far, which do not lead to reduction of infarct size and improvement of survival rate, and the efficacy has not been demonstrated.

Some explanations have been suggested for this phenomenon:

The operation method of device is complicated, and it is difficult to acquire the treatment technique.
Giant thrombus and solid lesion could not be aspirated effectively.
A lot of randomized studies have not focused on the "patients with anterior descending lesion of thrombolysis in myocardial infarction (TIMI) grade 0/1, of which the time from onset to treatment is within 6 hours," considered to have the largest benefit of prevention of no-reflow.

In recent years in Japan, excimer laser coronary angioplasty (ELCA) has been used in the patients with acute coronary syndrome (ACS), and not only debulking of arteriosclerotic lesion but also thrombolytic effect have been reported. In the Camel trial and Utility of Laser for Transcatheter Atherectomy Multicenter Analysis around Naniwa (ULTRAMAN) registry, the efficacy and safety in ACS have been reported, but the infarct size has not been evaluated.

This time in this study, it is considered that verification whether or not ELCA is able to improve the myocardial salvage in anterior ST elevation myocardial infarction (STEMI) using myocardial scintigram (acute-phase BMIPP and chronic-phase TF) will provide the useful information helpful for selection of treatment to medical care staffs and patients for future patients suffering from ACS and will be able to contribute to further improvement of medical science and medical practice.

MRI will be performed twice at 5-9 days and at 6 months post index ST elevation myocardial infarction to assess myocardial damage and functional variables, which details will be described in the following outcome measurement section.

Conditions: STEMI - ST Elevation Myocardial Infarction
Being tested: Excimer laser catheter
Keywords: ELCA, STEMI, Myocardial Salvage
Medical subject headings: ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Excimer laser catheterDevice
The excimer laser catheter is equipped with multiple optical fibers on the periphery of the guide wire lumen corresponding to 0.014 inch, which is used for the purpose of reperfusion of barrier site of coronary artery. The connector on the front side is connected with the CVX-300 laser generator, and the tip at the top contact directly with the lesion. The laser catheter consisting of multiple optical fibers transmits the energy in the ultraviolet region from the CVX300 laser generator to the blockage in the blood vessel. The ultraviolet energy is transmitted from the tip of laser catheter, transpires the fibrous, calcified and arteriosclerotic lesion by light, and enables reperfusion in the lesion. The laser catheter has appropriate hydrophilic coating and easily follows the inside of coronary artery.

Study groups in NCT03950310
Study group	Role	What they receive
ELCA	Experimental	On the antegrade delivery of the laser catheter after wiring, we used safe laser techniques and injected saline before and during the laser procedure at a 0.5 mm/sec catheter advancement rate. Whether to perform a retrograde laser method depended on each operator. After ablation by ELCA, patients undergo balloon dilation via standard techniques, and as appropriate, receive drug-eluting stent deployment. Receives: Device: Excimer laser catheter
non ELCA	No intervention	In non ELCA group, the conventional PCI procedure, including thrombus aspiration, POBA, and stent implantation was performed. The indication for aspiration was at the discretion of the physician based on angiographic, intravascular ultrasound, or optical coherence tomography/Optical Frequency-Domain Imaging.

What is being measured

The primary outcome is the main question the study is designed to answer.

myocardial salvage (17 segment model) by SPECT
Calculation of score using software in the Core Lab (Tokai University, Department of Radiology). Scoring should be conducted in 17 segments and at 5 grades from 0 to 4 in each segment on the polar map images. The Myocardial salvage (17-segment) was calculated by subtracting the total sum of the 123I-BMIPP and 99mTc-tetrofosmin defect scores in each segment ( ∑123I-BMIPP defect score minus 99mTc-∑tetrofosmin defect score).
Measured: 3 day to 6 month
Myocardial Salvage index (17 segment model) by SPECT
Salvage index was calculated as follows: Myocardial Salvage index =∑123I-BMIPP defect score minus ∑99mTc-tetrofosmin defect score/ ∑123I-BMIPP defect score × 100 (%).
Measured: 3 day to 6 month

Secondary outcomes (18)

Myocardial scar amount assessment by MRI
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Myocardial scar amount assessed on Late Short Axis LGE image
Measured: 5-9 days and 6 month
Microvascular obstruction assessment by MRI
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Microvascular obstruction on perfusion image and Early Short Axis LGE image
Measured: 5-9 days and 6 month
Myocardial salvage assessment by MRI
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Myocardial salvage derived from T2WBB and Late Short Axis LGE images
Measured: 5-9 days and 6 month
Ejection fraction assessment by MRI
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Ejection Fraction derived from Cine images
Measured: 5-9 days and 6 month
Gray zone assessment by MRI
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Gray zone derived from Late Short Axis LGE images.
Measured: 5-9 days and 6 month
Left ventricular ejection fraction by TF scintigraphy at 6 months
99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. ejection fraction (%) based on 99mTc-tetrofosmin QGS data.
Measured: 5-7 month
Left ventricular volume (ml) by TF scintigraphy at 6 months
99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular volume (ml) based on 99mTc-tetrofosmin QGS data.
Measured: 5-7 month
Left ventricular end-diastolic volume (ml) by TF scintigraphy at 6 months
99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular end-diastolic volume (ml) based on 99mTc-tetrofosmin QGS data.
Measured: 5-7 month
Left ventricular end-systolic volume (ml) by TF scintigraphy at 6 months
99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular end-systolic volume (ml) on 99mTc-tetrofosmin QGS data.
Measured: 5-7 month
Intra-stent tissue volume by OCT
OCT analysis should be conducted by an independent core lab (Kobe University Hospital) before and after stenting at Primary PCI and 1 year after PCI in selected patients. Should be conducted preoperatively, postoperatively and 1 year after operation. For analysis, the required matters (catheter size and target lesion) should be entered into the technician worksheet. The size and length of the stent used should be entered, in particular. In conducting OCI imaging in each medical institution, attention should be paid to the following points, and the requirements should be entered in the given section of technician worksheet: Analysis should be conducted based on the stent length described in the technician worksheet. In the qualitative analysis, the inside of stent and 5 mm to proximal and distal ends of stent should be evaluated at the interval of 0.2 mm. In the quantitative analysis, the inside of stent should be evaluated at the interval of 1.0 mm.
Measured: at the end of procedure and 1-year
Myocardial salvage [total perfusion defect (TPD) model] by SPECT
Myocardial salvage [total perfusion defect model (TPD)] = (Risk at area: TPD measured by BMIPP 3-9 days after p-PCI) minus (Infarct size: TPD measured by Tc99m-tetrofosmin at 6 months after p-PCI)
Measured: 3 day to 6 month
Myocardial salvage index (%) [total perfusion defect (TPD) model] by SPECT
Myocardial salvage index (%) [total perfusion defect model (TPD)] = myocardial salvage / Risk at area: TPD measured by BMIPP 3-9 days after p-PCI x 100
Measured: 3 day to 6 month
Major adverse cardiovascular events (MACE) at 12 months
Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR).
Measured: 12 months
Major adverse cardiovascular events (MACE) at 36 months
Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR).
Measured: 36 months
Major adverse cardiovascular events (MACE) at 60 months
Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR).
Measured: 60 months
Cardiac death at 12 months
Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified.
Measured: 12 months
Cardiac death at 36 months
Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified.
Measured: 36 months
Cardiac death at 60 months
Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified.
Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 201831 Dec 2021

First posted15 May 2019
Study start26 Jul 2018
Primary completion31 Dec 2021
Study completion31 Dec 2021

Why it stopped: Due to COVID19, primary PCI number reduced.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03950310
Sponsor's protocol ID: LASTPASS
Status last verified: Sep 2022
First submitted: 20 Apr 2019
Last updated: 3 Oct 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Giugliano RP, Braunwald E; TIMI Study Group. Selecting the best reperfusion strategy in ST-elevation myocardial infarction: it's all a matter of time. Circulation. 2003 Dec 9;108(23):2828-30. doi: 10.1161/01.CIR.0000106684.71725.98. No abstract available.
PubMed 14662688
Tanaka A, Kawarabayashi T, Nishibori Y, Sano T, Nishida Y, Fukuda D, Shimada K, Yoshikawa J. No-reflow phenomenon and lesion morphology in patients with acute myocardial infarction. Circulation. 2002 May 7;105(18):2148-52. doi: 10.1161/01.cir.0000015697.59592.07.
PubMed 11994247
Gupta S, Gupta MM. No reflow phenomenon in percutaneous coronary interventions in ST-segment elevation myocardial infarction. Indian Heart J. 2016 Jul-Aug;68(4):539-51. doi: 10.1016/j.ihj.2016.04.006. Epub 2016 Apr 19.
PubMed 27543480
Morishima I, Sone T, Okumura K, Tsuboi H, Kondo J, Mukawa H, Matsui H, Toki Y, Ito T, Hayakawa T. Angiographic no-reflow phenomenon as a predictor of adverse long-term outcome in patients treated with percutaneous transluminal coronary angioplasty for first acute myocardial infarction. J Am Coll Cardiol. 2000 Oct;36(4):1202-9. doi: 10.1016/s0735-1097(00)00865-2.
PubMed 11028471
Ito H, Maruyama A, Iwakura K, Takiuchi S, Masuyama T, Hori M, Higashino Y, Fujii K, Minamino T. Clinical implications of the 'no reflow' phenomenon. A predictor of complications and left ventricular remodeling in reperfused anterior wall myocardial infarction. Circulation. 1996 Jan 15;93(2):223-8. doi: 10.1161/01.cir.93.2.223.
PubMed 8548892
De Luca G, Ernst N, Zijlstra F, van 't Hof AW, Hoorntje JC, Dambrink JH, Gosslink AT, de Boer MJ, Suryapranata H. Preprocedural TIMI flow and mortality in patients with acute myocardial infarction treated by primary angioplasty. J Am Coll Cardiol. 2004 Apr 21;43(8):1363-7. doi: 10.1016/j.jacc.2003.11.042.
PubMed 15093868
Rezkalla SH, Kloner RA. No-reflow phenomenon. Circulation. 2002 Feb 5;105(5):656-62. doi: 10.1161/hc0502.102867. No abstract available.
PubMed 11827935
Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, Turco M, Schultheiss HP, Dulas D, Rutherford BD, Antoniucci D, Krucoff MW, Gibbons RJ, Jones D, Lansky AJ, Mehran R; Enhanced Myocardial Efficacy and Recovery by Aspiration of Liberated Debris (EMERALD) Investigators. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial. JAMA. 2005 Mar 2;293(9):1063-72. doi: 10.1001/jama.293.9.1063.
PubMed 15741528
Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, Suzuki T, Yamashita T, Takizawa A, Misumi K, Hashimoto H, Isshiki T; VAMPIRE Investigators. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):424-31. doi: 10.1016/j.jcin.2008.06.004.
PubMed 19463340
Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.
PubMed 18539223
Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.
PubMed 25853743
Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa1308789. Epub 2013 Aug 31.
PubMed 23991656
Stone GW, Dixon SR, Grines CL, Cox DA, Webb JG, Brodie BR, Griffin JJ, Martin JL, Fahy M, Mehran R, Miller TD, Gibbons RJ, O'Neill WW. Predictors of infarct size after primary coronary angioplasty in acute myocardial infarction from pooled analysis from four contemporary trials. Am J Cardiol. 2007 Nov 1;100(9):1370-5. doi: 10.1016/j.amjcard.2007.06.027. Epub 2007 Aug 17.
PubMed 17950792
Nikolsky E, Stone GW, Lee E, Lansky AJ, Webb J, Cox DA, Brodie BR, Turco MA, Rutherford BD, Kalynych AM, Antoniucci D, Krucoff MW, Gibbons RJ, Fahy M, Mehran R. Correlations between epicardial flow, microvascular reperfusion, infarct size and clinical outcomes in patients with anterior versus non-anterior myocardial infarction treated with primary or rescue angioplasty: analysis from the EMERALD trial. EuroIntervention. 2009 Sep;5(4):417-24. doi: 10.4244/eijv5i4a66.
PubMed 19755327
Topaz O, Minisi AJ, Bernardo NL, McPherson RA, Martin E, Carr SL, Carr ME Jr. Alterations of platelet aggregation kinetics with ultraviolet laser emission: the "stunned platelet" phenomenon. Thromb Haemost. 2001 Oct;86(4):1087-93.
PubMed 11686328

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)

All STEMI - ST Elevation Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Myocardial Salvage by Scintigraphy After Excimer Laser Coronary Angioplasty and Percutaneous Coronary Intervention With Biodegradable-polymer Platinum Chromium Everolimus-eluting Stent in the Patients With Anterior ST Elevation Myocardial Infarction
ClinicalTrials.gov ID: NCT03950310
Acronym / sponsor ID: LASTPASS
Conditions: STEMI - ST Elevation Myocardial Infarction
Keywords: ELCA, STEMI, Myocardial Salvage
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to COVID19, primary PCI number reduced.
Enrolment: 142 participants (actual)
Lead sponsor: Tokai UniversityUniversity, hospital or other
Study start: 26 Jul 2018 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 15 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Some explanations have been suggested for this phenomenon:

The operation method of device is complicated, and it is difficult to acquire the treatment technique.
Giant thrombus and solid lesion could not be aspirated effectively.
A lot of randomized studies have not focused on the "patients with anterior descending lesion of thrombolysis in myocardial infarction (TIMI) grade 0/1, of which the time from onset to treatment is within 6 hours," considered to have the largest benefit of prevention of no-reflow.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ELCA	Experimental	Device: Excimer laser catheterOn the antegrade delivery of the laser catheter after wiring, we used safe laser techniques and injected saline before and during the laser procedure at a 0.5 mm/sec catheter advancement rate. Whether to perform a retrograde laser method depended on each operator. After ablation by ELCA, patients undergo balloon dilation via standard techniques, and as appropriate, receive drug-eluting stent deployment.
non ELCA	No intervention	–In non ELCA group, the conventional PCI procedure, including thrombus aspiration, POBA, and stent implantation was performed. The indication for aspiration was at the discretion of the physician based on angiographic, intravascular ultrasound, or optical coherence tomography/Optical Frequency-Domain Imaging.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Excimer laser catheterThe excimer laser catheter is equipped with multiple optical fibers on the periphery of the guide wire lumen corresponding to 0.014 inch, which is used for the purpose of reperfusion of barrier site of coronary artery. The connector on the front side is connected with the CVX-300 laser generator, and the tip at the top contact directly with the lesion. The laser catheter consisting of multiple optical fibers transmits the energy in the ultraviolet region from the CVX300 laser generator to the blockage in the blood vessel. The ultraviolet energy is transmitted from the tip of laser catheter, transpires the fibrous, calcified and arteriosclerotic lesion by light, and enables reperfusion in the lesion. The laser catheter has appropriate hydrophilic coating and easily follows the inside of coronary artery.	Device	ELCA

Primary outcome

myocardial salvage (17 segment model) by SPECT
Time frame: 3 day to 6 month
Calculation of score using software in the Core Lab (Tokai University, Department of Radiology). Scoring should be conducted in 17 segments and at 5 grades from 0 to 4 in each segment on the polar map images. The Myocardial salvage (17-segment) was calculated by subtracting the total sum of the 123I-BMIPP and 99mTc-tetrofosmin defect scores in each segment ( ∑123I-BMIPP defect score minus 99mTc-∑tetrofosmin defect score).
Myocardial Salvage index (17 segment model) by SPECT
Time frame: 3 day to 6 month
Salvage index was calculated as follows: Myocardial Salvage index =∑123I-BMIPP defect score minus ∑99mTc-tetrofosmin defect score/ ∑123I-BMIPP defect score × 100 (%).

18 secondary outcomes

Myocardial scar amount assessment by MRI
Time frame: 5-9 days and 6 month
Microvascular obstruction assessment by MRI
Time frame: 5-9 days and 6 month
Myocardial salvage assessment by MRI
Time frame: 5-9 days and 6 month
Ejection fraction assessment by MRI
Time frame: 5-9 days and 6 month
Gray zone assessment by MRI
Time frame: 5-9 days and 6 month
Left ventricular ejection fraction by TF scintigraphy at 6 months
Time frame: 5-7 month
Left ventricular volume (ml) by TF scintigraphy at 6 months
Time frame: 5-7 month
Left ventricular end-diastolic volume (ml) by TF scintigraphy at 6 months
Time frame: 5-7 month
Left ventricular end-systolic volume (ml) by TF scintigraphy at 6 months
Time frame: 5-7 month
Intra-stent tissue volume by OCT
Time frame: at the end of procedure and 1-year
Myocardial salvage [total perfusion defect (TPD) model] by SPECT
Time frame: 3 day to 6 month
Myocardial salvage index (%) [total perfusion defect (TPD) model] by SPECT
Time frame: 3 day to 6 month
Major adverse cardiovascular events (MACE) at 12 months
Time frame: 12 months
Major adverse cardiovascular events (MACE) at 36 months
Time frame: 36 months
Major adverse cardiovascular events (MACE) at 60 months
Time frame: 60 months
Cardiac death at 12 months
Time frame: 12 months
Cardiac death at 36 months
Time frame: 36 months
Cardiac death at 60 months
Time frame: 60 months

Results and safety

The study was stopped early (reason given: Due to COVID19, primary PCI number reduced.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
Background: PubMed 14662688Giugliano RP, Braunwald E; TIMI Study Group. Selecting the best reperfusion strategy in ST-elevation myocardial infarction: it's all a matter of time. Circulation. 2003 Dec 9;108(23):2828-30. doi: 10.1161/01.CIR.0000106684.71725.98. No abstract available.
Background: PubMed 11994247Tanaka A, Kawarabayashi T, Nishibori Y, Sano T, Nishida Y, Fukuda D, Shimada K, Yoshikawa J. No-reflow phenomenon and lesion morphology in patients with acute myocardial infarction. Circulation. 2002 May 7;105(18):2148-52. doi: 10.1161/01.cir.0000015697.59592.07.
Background: PubMed 27543480Gupta S, Gupta MM. No reflow phenomenon in percutaneous coronary interventions in ST-segment elevation myocardial infarction. Indian Heart J. 2016 Jul-Aug;68(4):539-51. doi: 10.1016/j.ihj.2016.04.006. Epub 2016 Apr 19.
Background: PubMed 11028471Morishima I, Sone T, Okumura K, Tsuboi H, Kondo J, Mukawa H, Matsui H, Toki Y, Ito T, Hayakawa T. Angiographic no-reflow phenomenon as a predictor of adverse long-term outcome in patients treated with percutaneous transluminal coronary angioplasty for first acute myocardial infarction. J Am Coll Cardiol. 2000 Oct;36(4):1202-9. doi: 10.1016/s0735-1097(00)00865-2.
Background: PubMed 8548892Ito H, Maruyama A, Iwakura K, Takiuchi S, Masuyama T, Hori M, Higashino Y, Fujii K, Minamino T. Clinical implications of the 'no reflow' phenomenon. A predictor of complications and left ventricular remodeling in reperfused anterior wall myocardial infarction. Circulation. 1996 Jan 15;93(2):223-8. doi: 10.1161/01.cir.93.2.223.
Background: PubMed 15093868De Luca G, Ernst N, Zijlstra F, van 't Hof AW, Hoorntje JC, Dambrink JH, Gosslink AT, de Boer MJ, Suryapranata H. Preprocedural TIMI flow and mortality in patients with acute myocardial infarction treated by primary angioplasty. J Am Coll Cardiol. 2004 Apr 21;43(8):1363-7. doi: 10.1016/j.jacc.2003.11.042.
Background: PubMed 11827935Rezkalla SH, Kloner RA. No-reflow phenomenon. Circulation. 2002 Feb 5;105(5):656-62. doi: 10.1161/hc0502.102867. No abstract available.
Background: PubMed 15741528Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, Turco M, Schultheiss HP, Dulas D, Rutherford BD, Antoniucci D, Krucoff MW, Gibbons RJ, Jones D, Lansky AJ, Mehran R; Enhanced Myocardial Efficacy and Recovery by Aspiration of Liberated Debris (EMERALD) Investigators. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial. JAMA. 2005 Mar 2;293(9):1063-72. doi: 10.1001/jama.293.9.1063.
Background: PubMed 19463340Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, Suzuki T, Yamashita T, Takizawa A, Misumi K, Hashimoto H, Isshiki T; VAMPIRE Investigators. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):424-31. doi: 10.1016/j.jcin.2008.06.004.
Background: PubMed 18539223Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.
Background: PubMed 25853743Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.
Background: PubMed 23991656Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa1308789. Epub 2013 Aug 31.

Related trials for STEMI - ST Elevation Myocardial Infarction

RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Excimer laser catheter in people with STEMI - ST Elevation Myocardial Infarction, run by Tokai University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to COVID19, primary PCI number reduced.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

myocardial salvage (17 segment model) by SPECT (time frame: 3 day to 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03950310, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.