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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

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

Conditions
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Cardiovascular Diseases, Arterial Disease

Intervention / Treatment
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* Procedure: NC ( Non- Compliant) Balloon dilatation
* Procedure: Laser Excimer + NC Balloon


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LASER EXPAND