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Coronary Laser in Undilatable or Uncrossable Lesions | Clinical Trials | Clareo Health

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Coronary Laser in Undilatable or Uncrossable Lesions

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

NCT07206082•Hospital Universitario La Paz

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hospital Universitario La Paz

Madrid, Madrid, Spain

Key Dates

Start Date

June 5, 2020

Primary Completion Date

March 10, 2025

Completion Date

October 20, 2025

Last Updated

October 3, 2025

Enrollment

230

ESTIMATED participants

Conditions

Coronary Artery DiseaseCalcified Coronary Artery DiseaseIn Stent RestenosisChronic Total Occlusion (CTO)

Interventions

Laser atherectomy

DEVICE

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Coronary Laser in Undilatable or Uncrossable Lesions

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

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