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NCT Number: NCT07206082

Coronary Laser in Undilatable or Uncrossable Lesions

This will be an investigator-initiated, multicentre, single-arm, open-label, prospective observational study. Patients with indication for PCI and undilatable (non-compliant balloon dilatation <80% at burst pressure) or uncrossable (not crossable with a "small-profile balloon" with adequate support, according to operator´s discretion) coronary lesions treated with ELCA will be included. Intravascular imaging will be highly recommendable and analysed in a central core-laboratory. Device success, angiographical success, procedural success, clinical success and related complications will be evaluated. Patients will be followed for 1 year after the procedure and clinical events will be recorded.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Calcified Coronary Artery Disease Cardiovascular Diseases Chronic Total Occlusion (CTO) Coronary Disease Heart Diseases In Stent Restenosis Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario La Paz

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged over 18 years.
  • Patients with either stable coronary artery disease or acute coronary syndromes as the clinical presentation.
  • Patients with severe coronary lesions (>70% by visual estimation) in native vessels or coronary bypass grafts.
  • "Uncrossable" coronary lesions (i.e., lesions that cannot be crossed with a 0.7:1 balloon after successful guidewire passage) or "Undilatable" lesions (i.e., those in which balloon dilation with a 1:1 non-compliant balloon at 18 atm results in less than 80% expansion relative to the distal reference vessel diameter; this group includes both de novo lesions and in-stent restenosis or underexpanded stents).

Exclusion criteria

  • Patients with known allergies to aspirin (ASA), clopidogrel, prasugrel, or ticagrelor.
  • Patients unable to provide informed consent, either personally or through a legal representative.
  • Patients with clinical or hemodynamic instability defined as: sustained hypotension (systolic blood pressure ≤ 90 mmHg for ≥ 30 minutes or use of pharmacological and/or mechanical support to maintain an SBP ≥90 mmHg) or evidence of end-organ hypoperfusion including urine output of <30 mL/h, cool extremities, altered mental status, and/or serum lactate >2.0 mmol/L.
  • Patients with significant comorbidities and a life expectancy of less than one year.

Treatment and study plan

Laser Atherectomy

Device

ELCA procedure will be performed using the Spectranetics CVX300 (Spectranetics, Colorado Spring, CO, USA) and the latest generation Philips Laser System Excimer (Philips, San Diego, CA, USA) System, which is based on pulsed xenon-chlorine laser catheters capable of delivering excimer energy (wavelength 308 nm, pulse length 185 ns) from 30 to 80 mJ/mm2 (fluencies) at pulse repetition rates from 25 to 80 Hz.

The ELCA technique will be performed according to current recommendations (18). The laser probe size will be at the operator´s discretion among the available options (rapid exchange concentric 0.9 mm, 1.4 mm, 1.7mm or 2.0mm). The selection of fluence, and repetition rate will be left to the operator. A saline infusion technique will be recommended, although application of laser with blood or contrast will be recommended in resistant lesions. In the event of unsuccessful initial therapy, additional plaque modification techniques may be employed at the discretion of the operator and wi

Primary outcomes

  1. Laser Success

    Time frame: From enrollment to the end of the procedure at 4 hours.

    For uncrossable lesions, it will be defined as the ability of the laser catheter to cross the lesion. Laser success will be also considered in cases in which the laser catheter cannot cross the lesion but its application proximal to it allows subsequent crossing of balloons. For undilatable lesions, laser success will be defined as successful balloon dilation (sized 1:1 to the vessel diameter), with adequate expansion (>80% in two orthogonal projections) following laser therapy without the need of other plaque modification technique.

Secondary outcomes

  1. Angiographic success

    Time frame: From enrollment to the end of the procedure at 4 hours.

    Thrombolysis in myocardial infarction (TIMI) 3 final flow and a diameter stenosis <20%.

  2. Procedural success

    Time frame: From enrollment to the end of the procedure at 4 hours.

    Angiographic success without severe procedural complications (death, coronary perforation, abrupt vessel closure, flow-limiting dissection).

  3. Intracoronary imaging-based success

    Time frame: From enrollment to the end of the procedure at 4 hours.

    Stent expansion ≥80% [OCT or intravascular ultrasound (IVUS)] or a minimal stent area (MSA) ≥4.5mm2 in OCT or ≥5.5mm2 in IVUS.

  4. Events at 1 year

    Time frame: From enrollment to 1 year after the procedure

    Clinical events and antiplatelet therapy will be recorded, including the rate of major cardiovascular events (MACE), defined as the occurrence of cardiac death, target vessel acute myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis), death, cardiovascular death, non-fatal MI, target lesion revascularization (TLR), TVR, stroke and bleeding.

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

LUDICO Study: Effectiveness and Safety of Coronary Laser in UnDIlatable or unCrOssable Lesions

Acronym: LUDICO

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

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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