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

Not Applicable

Completed

• Conditions: Arterial Disease; Cardiovascular Diseases
• Interventions: Procedure: NC ( Non- Compliant) Balloon dilatation; Procedure: Laser Excimer + NC Balloon

• Registration Number: NCT04359446
• Lead Sponsor: Fundación EPIC

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.

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Study Start: 2020-09-12
• Primary Completion: 2023-06-28
• Study Completion: 2023-06-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent under-expansion with NC Balloon	NC ( Non- Compliant) Balloon dilatation	-
Stent under-expansion with Laser Excimer + NC Balloon	Laser Excimer + NC Balloon	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
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.
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.
Procedure time	During procedure	Determination of the duration time of the procedure in minutes

Trial Locations

Locations (6)

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, Coruña, Spain

Hospital Universitario Juan Ramon Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Córdoba, Spain

Hospital Universitario Lucus Agusti; 🇪🇸 Lugo, Spain