Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent

Overview

The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.

Full Title of Study: “Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent (LASER EXPAND Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 28, 2023

Detailed Description

The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. The investigators propose a study that serves as proof of concept for this technology (laser Excimer) used according to its intended use in this specific substrate of coronary lesions. (stent under-expansion without severe underlying calcification).The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.

Interventions

  • Procedure: NC ( Non- Compliant) Balloon dilatation
    • NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each)
  • Procedure: Laser Excimer + NC Balloon
    • Laser Excimer + NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each)

Arms, Groups and Cohorts

  • Other: Stent under-expansion with NC Balloon
  • Other: Stent under-expansion with Laser Excimer + NC Balloon

Clinical Trial Outcome Measures

Primary Measures

  • Variation of the minimum luminal area (MLA)
    • Time Frame: During procedure
    • Detection of rate for Variation of the minimum luminal area (MLA) of the under-expanded stent defined as: ((MLAfinal-MLAinicial) / MLAinicial) x 100.

Secondary Measures

  • Hyperacute thrombosis (THA)
    • Time Frame: During procedure
    • Detection of rate for Hyperacute thrombosis defined as: (number of THA patients cases detected / number of total patients cases) x 100.
  • No- Reflow/Slow Flow (SFL)
    • Time Frame: During procedure
    • Detection of rate for no-reflow / slow flow rate (SFL), defined as (number of detected patients cases of SFL / number total cases) x 100.
  • Bradycardia
    • Time Frame: During procedure
    • Detection of rate for Bradycardia (HR <50 beats / min or reduction of HR during application> 30%) defined as: (number of detected patients cases of bradycardia / number of total patients cases) x 100.
  • Tachycardia
    • Time Frame: During procedure
    • Detection of rate for tachycardia, defined as: (ventricular or supraventricular tachycardias detected) during modification of the lesion, defined as (number of patients cases detected / number of total patients cases) x 100.
  • Procedure time
    • Time Frame: During procedure
    • Determination of the duration time of the procedure in minutes
  • Contrast Volume
    • Time Frame: During procedure
    • Determination of total contrast volume in mL
  • Complications during procedure
    • Time Frame: During procedure
    • Detection of rate for complications, defined as: (number of patients cases of coronary perforation, occlusive dissection of the vessel, intra-procedure death, myocardial infarction / total number of cases) x 100.
  • Periprocedural Infarction complications
    • Time Frame: During procedure
    • Detection of rate for periprocedural infarction complications, defined as: (number of patients cases of periprocedural infarction / total number of patients cases) x 100.

Participating in This Clinical Trial

Inclusion Criteria

Patients with:

  • Age ≥ 18 years. – Consecutive real-world patients, referred for cardiac catheterization for any cause, who present in any main vessel, bypass or in the common trunk an under-expanded stent tributary of being treated (minimum luminal area <4 mm2 or <6 mm2 in the left main coronary artery measured by IVUs (Intravascular Ultrasound) / OCT(Optical Coherence Tomography)) and that it is not possible to dilate with a NC balloon to a maximum of 20 atm. Exclusion Criteria:

  • Refusal of the patient to participate in the study. – Patients with life expectancy <1 year. – Patients with advanced kidney disease (grade IV) or liver failure (Child C)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación EPIC
  • Provider of Information About this Clinical Study
    • Sponsor

References

Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Gruntzig Lecture ESC 2014. Eur Heart J. 2015 Dec 14;36(47):3320-31. doi: 10.1093/eurheartj/ehv511. Epub 2015 Sep 28.

Veerasamy M, Gamal AS, Jabbar A, Ahmed JM, Egred M. Excimer Laser With and Without Contrast for the Management of Under-Expanded Stents. J Invasive Cardiol. 2017 Nov;29(11):364-369.

Egred M. A novel approach for under-expanded stent: excimer laser in contrast medium. J Invasive Cardiol. 2012 Aug;24(8):E161-3.

Lam SC, Bertog S, Sievert H. Excimer laser in management of underexpansion of a newly deployed coronary stent. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):E64-8. doi: 10.1002/ccd.25030. Epub 2013 Jul 1.

Egred M, Brilakis ES. Excimer Laser Coronary Angioplasty (ELCA): Fundamentals, Mechanism of Action, and Clinical Applications. J Invasive Cardiol. 2020 Feb;32(2):E27-E35.

Latib A, Takagi K, Chizzola G, Tobis J, Ambrosini V, Niccoli G, Sardella G, DiSalvo ME, Armigliato P, Valgimigli M, Tarsia G, Gabrielli G, Lazar L, Maffeo D, Colombo A. Excimer Laser LEsion modification to expand non-dilatable stents: the ELLEMENT registry. Cardiovasc Revasc Med. 2014 Jan;15(1):8-12. doi: 10.1016/j.carrev.2013.10.005. Epub 2013 Oct 22.

Ben-Dor I, Maluenda G, Pichard AD, Satler LF, Gallino R, Lindsay J, Waksman R. The use of excimer laser for complex coronary artery lesions. Cardiovasc Revasc Med. 2011 Jan-Feb;12(1):69.e1-8. doi: 10.1016/j.carrev.2010.06.008. Epub 2010 Oct 20.

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