Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent (LASER EXPAND)

Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent (LASER EXPAND Study)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Arterial Disease
• Intervention / Treatment: Procedure: NC ( Non- Compliant) Balloon dilatation; Procedure: Laser Excimer + NC Balloon

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Huelva, Spain, 21005
    • Hospital Universitario Juan Ramón Jiménez
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Agustí
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Coruña
    • Santiago De Compostela, Coruña, Spain, 15706
      • Hospital Clinico Universitario de Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stent under-expansion with NC Balloon	Procedure: NC ( Non- Compliant) Balloon dilatation; NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each)
Other: Stent under-expansion with Laser Excimer + NC Balloon	Procedure: Laser Excimer + NC Balloon; Laser Excimer + NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperacute thrombosis (THA)	Detection of rate for Hyperacute thrombosis defined as: (number of THA patients cases detected / number of total patients cases) x 100.	During procedure
No- Reflow/Slow Flow (SFL)	Detection of rate for no-reflow / slow flow rate (SFL), defined as (number of detected patients cases of SFL / number total cases) x 100.	During procedure
Bradycardia	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.	During procedure
Tachycardia	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.	During procedure
Procedure time	Determination of the duration time of the procedure in minutes	During procedure
Contrast Volume	Determination of total contrast volume in mL	During procedure
Complications 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.	During procedure
Periprocedural Infarction complications	Detection of rate for periprocedural infarction complications, defined as: (number of patients cases of periprocedural infarction / total number of patients cases) x 100.	During procedure

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2020
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: LASER EXPAND
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: EPIC16- LASER EXPAND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No