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

Fundación EPIC

Status

Completed

Conditions

Arterial Disease

Cardiovascular Diseases

Treatments

Procedure: Laser Excimer + NC Balloon

Procedure: NC ( Non- Compliant) Balloon dilatation

Study type

Interventional

Funder types

Other

Identifiers

NCT04359446

EPIC16- LASER EXPAND

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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