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

Cardiovascular Diseases Clinical Trial

— LASER EXPAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359446
• Other study ID #: EPIC16- LASER EXPAND
• Status: Completed
• Phase: N/A
• Start date: September 12, 2020
• Est. completion date: June 28, 2023

Study information

• Verified date: August 2023
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Disease
• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Universitario Juan Ramon Jimenez	Huelva
Spain	Hospital Universitario Lucus Agusti	Lugo
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Clinico Universitario de Santiago de Compostela	Santiago De Compostela	Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Procedure time	Determination of the duration time of the procedure in minutes	During procedure
Secondary	Contrast Volume	Determination of total contrast volume in mL	During procedure
Secondary	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
Secondary	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