Laser Atherectomy for ST Elevation Myocardial Infarction

NCT03950310 | Terminated DMC

• 1 other identifier: LASTPASS
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

ELCA; STEMI; Myocardial Salvage

Outcome Measures

Primary Outcomes (2)

• 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).

  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 (%).

  3 day to 6 month

Secondary Outcomes (18)

• Myocardial scar amount assessment by MRI

  5-9 days and 6 month

• Microvascular obstruction assessment by MRI

  5-9 days and 6 month

• Myocardial salvage assessment by MRI

  5-9 days and 6 month

• Ejection fraction assessment by MRI

  5-9 days and 6 month

• Gray zone assessment by MRI

  5-9 days and 6 month

Study Arms (2)

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.

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.

Interventions

Excimer laser catheter DEVICE

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.

ELCA

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tokai University: lead

Study Sites (1)

Tokai University School of Medicine

Isehara, Kanagawa, 259-1193, Japan

Location

Related Publications (19)

• 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.

  PMID: 14662688 BACKGROUND

• 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.

  PMID: 11994247 BACKGROUND

• 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.

  PMID: 27543480 BACKGROUND

• 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.

  PMID: 11028471 BACKGROUND

• 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.

  PMID: 8548892 BACKGROUND

• 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.

  PMID: 15093868 BACKGROUND

• Rezkalla SH, Kloner RA. No-reflow phenomenon. Circulation. 2002 Feb 5;105(5):656-62. doi: 10.1161/hc0502.102867. No abstract available.

  PMID: 11827935 BACKGROUND

• 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.

  PMID: 15741528 BACKGROUND

• 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.

  PMID: 19463340 BACKGROUND

• 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.

  PMID: 18539223 BACKGROUND

• 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.

  PMID: 25853743 BACKGROUND

• 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.

  PMID: 23991656 BACKGROUND

• 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.

  PMID: 17950792 BACKGROUND

• 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.

  PMID: 19755327 BACKGROUND

• 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.

  PMID: 11686328 BACKGROUND

• Topaz O, Bernardo NL, Shah R, McQueen RH, Desai P, Janin Y, Lansky AJ, Carr ME. Effectiveness of excimer laser coronary angioplasty in acute myocardial infarction or in unstable angina pectoris. Am J Cardiol. 2001 Apr 1;87(7):849-55. doi: 10.1016/s0002-9149(00)01525-3.

  PMID: 11274939 BACKGROUND

• Nishino M, Mori N, Takiuchi S, Shishikura D, Doi N, Kataoka T, Ishihara T, Kinoshita N; ULTRAMAN Registry investigators. Indications and outcomes of excimer laser coronary atherectomy: Efficacy and safety for thrombotic lesions-The ULTRAMAN registry. J Cardiol. 2017 Jan;69(1):314-319. doi: 10.1016/j.jjcc.2016.05.018. Epub 2016 Jul 2.

  PMID: 27381939 BACKGROUND

• Rawlins J, Din JN, Talwar S, O'Kane P. Coronary Intervention with the Excimer Laser: Review of the Technology and Outcome Data. Interv Cardiol. 2016 May;11(1):27-32. doi: 10.15420/icr.2016:2:2.

  PMID: 29588701 BACKGROUND

• Kato Y, Lee WH, Natsumeda M, Ambale-Venkatesh B, Takagi K, Ikari Y, Lima JAC. Left atrial diastasis strain slope is a marker of hemodynamic recovery in post-ST elevation myocardial infarction: the Laser Atherectomy for STemi, Pci Analysis with Scintigraphy Study (LAST-PASS). Front Radiol. 2024 Feb 21;4:1294398. doi: 10.3389/fradi.2024.1294398. eCollection 2024.

  PMID: 38450099 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open -but assessors are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: April 20, 2019
• First Posted: May 15, 2019
• Study Start: July 26, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

JP (1)