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Completed

NCT Number: NCT04359446

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

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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Key information

Conditions

Cardiovascular Diseases Arterial Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NC ( Non- Compliant) Balloon dilatation

Procedure

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

Laser Excimer + NC Balloon

Procedure

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

Primary outcomes

  1. Variation of the minimum luminal area (MLA)

    Time frame: 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 outcomes

  1. Hyperacute thrombosis (THA)

    Time frame: During procedure

    Detection of rate for Hyperacute thrombosis defined as: (number of THA patients cases detected / number of total patients cases) x 100.

  2. No- Reflow/Slow Flow (SFL)

    Time frame: 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.

  3. Bradycardia

    Time frame: 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.

  4. Tachycardia

    Time frame: 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.

  5. Procedure time

    Time frame: During procedure

    Determination of the duration time of the procedure in minutes

  6. Contrast Volume

    Time frame: During procedure

    Determination of total contrast volume in mL

  7. Complications during procedure

    Time frame: 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.

  8. Periprocedural Infarction complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

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

Acronym: LASER EXPAND

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2020
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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