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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-12

Study Completion Date

2023-06-28

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.

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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.

Conditions

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Cardiovascular Diseases Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stent under-expansion with NC Balloon

Group Type OTHER

NC ( Non- Compliant) Balloon dilatation

Intervention Type PROCEDURE

NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)

Stent under-expansion with Laser Excimer + NC Balloon

Group Type OTHER

Laser Excimer + NC Balloon

Intervention Type PROCEDURE

Laser Excimer + NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)

Interventions

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NC ( Non- Compliant) Balloon dilatation

NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)

Intervention Type PROCEDURE

Laser Excimer + NC Balloon

Laser Excimer + NC Balloon dilatation at pressure \> NC-RBP (18-20 atm) with \> 1 long inflation (\> 20 minutes each)

Intervention Type PROCEDURE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No