NCT04359446

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Arterial Disease

Interventions

Type	Name	Description
PROCEDURE	NC ( Non- Compliant) Balloon dilatation	NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)
PROCEDURE	Laser Excimer + NC Balloon	Laser Excimer + NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)

Timeline

• Start date: 2020-09-12
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2020-04-24
• Last updated: 2023-08-08

Locations

6 sites across 1 country: Spain