Coronary Laser in Undilatable or Uncrossable Lesions (LUDICO)

Madrid Health Service

Status

Active, not recruiting

Conditions

In Stent Restenosis

Coronary Artery Disease

Calcified Coronary Artery Disease

Chronic Total Occlusion (CTO)

Treatments

Device: Laser atherectomy

Study type

Observational

Funder types

Other

Identifiers

NCT07206082

5502

Details and patient eligibility

About

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.

Enrollment

230 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.