Coronary Laser in Undilatable or Uncrossable Lesions

Active, not recruiting

• Conditions: Coronary Artery Disease; Calcified Coronary Artery Disease; In Stent Restenosis; Chronic Total Occlusion (CTO)

• Registration Number: NCT07206082
• Lead Sponsor: Hospital Universitario La Paz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-05
• Primary Completion: 2025-03-10
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Laser Success	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 Outcome Measures

Name	Time	Method
Angiographic success	From enrollment to the end of the procedure at 4 hours.	Thrombolysis in myocardial infarction (TIMI) 3 final flow and a diameter stenosis \<20%.
Procedural success	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).
Intracoronary imaging-based success	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.
Events at 1 year	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.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Madrid, Spain