Arterial Disease, Cardiovascular Diseases
Conditions
Keywords
LASER EXPAND
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.
Interventions
PROCEDURENC ( Non- Compliant) Balloon dilatation
NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)
PROCEDURELaser Excimer + NC Balloon
Laser Excimer + NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)
Sponsors
Fundación EPIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of the minimum luminal area (MLA) | During procedure | Detection of rate for Variation of the minimum luminal area (MLA) of the under-expanded stent defined as: ((MLAfinal-MLAinicial) / MLAinicial) x 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No- Reflow/Slow Flow (SFL) | During procedure | Detection of rate for no-reflow / slow flow rate (SFL), defined as (number of detected patients cases of SFL / number total cases) x 100. |
| Bradycardia | During procedure | 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. |
| Tachycardia | During procedure | 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. |
| Hyperacute thrombosis (THA) | During procedure | Detection of rate for Hyperacute thrombosis defined as: (number of THA patients cases detected / number of total patients cases) x 100. |
| Contrast Volume | During procedure | Determination of total contrast volume in mL |
| Complications during procedure | 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. |
| Periprocedural Infarction complications | During procedure | Detection of rate for periprocedural infarction complications, defined as: (number of patients cases of periprocedural infarction / total number of patients cases) x 100. |
| Procedure time | During procedure | Determination of the duration time of the procedure in minutes |
Countries
Spain
Outcome results
None listed