Coronary Laser in Undilatable or Uncrossable Lesions

NCT ID: NCT07206082

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-05
• Study Completion Date: 2025-10-20

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

undilatable lesions

expansion \<80% of the distal vessel diameter after inflation of a 1:1 non-compliant balloon at 18 atm

Laser atherectomy

Intervention Type: 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

uncrossable coronary lesions

(not crossable after using a small-profile balloon with adequate support, according to operator´s discretion

Laser atherectomy

Intervention Type: 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

Interventions

Laser atherectomy

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Alfonso Jurado, MD, PhD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario La Paz

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

5502

Identifier Type: -

Identifier Source: org_study_id