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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent under-expansion with NC Balloon | Other |
| |
| Stent under-expansion with Laser Excimer + NC Balloon | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NC ( Non- Compliant) Balloon dilatation | Procedure | NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each) |
|
| 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 |
| 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) |
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Inclusion Criteria:
Patients with:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario de Santiago de Compostela | Santiago de Compostela | Coruña | 15706 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26417060 | Background | 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. | |
| 29086727 | Background | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054018 | Lasers, Excimer |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Laser Excimer + NC Balloon | Procedure | Laser Excimer + NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each) |
|
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 |
| Hospital Universitari Vall D'Hebron |
| Barcelona |
| 08035 |
| Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Hospital Universitario Lucus Agusti | Lugo | 27003 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| 22865316 | Background | Egred M. A novel approach for under-expanded stent: excimer laser in contrast medium. J Invasive Cardiol. 2012 Aug;24(8):E161-3. |
| 23703809 | Background | 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. |
| 32005787 | Background | 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. |
| 24290659 | Background | 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. |
| 21241980 | Background | 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. |