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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)
Laser Excimer + NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Coruña, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain
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.
Time frame: During procedure
Hyperacute thrombosis (THA)
Detection of rate for Hyperacute thrombosis defined as: (number of THA patients cases detected / number of total patients cases) x 100.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During procedure
Procedure time
Determination of the duration time of the procedure in minutes
Time frame: During procedure
Contrast Volume
Determination of total contrast volume in mL
Time frame: During procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Universitario Lucus Agusti
Lugo, Spain
Hospital Universitario La Paz
Madrid, Spain
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.
Time frame: 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.
Time frame: During procedure