Clinical trial NCT04359446: Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent
Official title: Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent (LASER EXPAND Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Arterial Disease
Keywords: LASER EXPAND
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Variation of the minimum luminal area (MLA)
timeFrame: During procedure
Secondary outcomes:
measure: Hyperacute thrombosis (THA)
timeFrame: During procedure
measure: No- Reflow/Slow Flow (SFL)
timeFrame: During procedure
measure: Bradycardia
timeFrame: During procedure
measure: Tachycardia
timeFrame: During procedure
measure: Procedure time
timeFrame: During procedure
measure: Contrast Volume
timeFrame: During procedure
measure: Complications during procedure
timeFrame: During procedure
measure: Periprocedural Infarction complications
timeFrame: During procedure
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: Coruña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Agusti
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
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.
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.
citation: Egred M. A novel approach for under-expanded stent: excimer laser in contrast medium. J Invasive Cardiol. 2012 Aug;24(8):E161-3.
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.
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. doi: 10.25270/jic/19.00325.
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.
citation: 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.