Coronary Laser in Undilatable or Uncrossable Lesions

NCT07206082 | Active Not Recruiting FDA Device

• 1 other identifier: 5502
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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)

Keywords

Percutaneous coronary intervention; excimer laser coronary atherectomy; intravascular imaging; optical coherence tomography; complex coronary intervention

Outcome Measures

Primary Outcomes (1)

• Laser Success

  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.

  From enrollment to the end of the procedure at 4 hours.

Secondary Outcomes (4)

• Angiographic success

  From enrollment to the end of the procedure at 4 hours.

• Procedural success

  From enrollment to the end of the procedure at 4 hours.

• Intracoronary imaging-based success

  From enrollment to the end of the procedure at 4 hours.

• Events at 1 year

  From enrollment to 1 year after the procedure

Study Arms (2)

undilatable lesions

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

Device: Laser atherectomy

uncrossable coronary lesions

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

Device: Laser atherectomy

Interventions

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

uncrossable coronary lesions; undilatable lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with indication for PCI and undilatable or uncrossable lesions treated with ELCA

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 3, 2025
• Study Start: June 5, 2020
• Primary Completion: March 10, 2025
• Study Completion: October 20, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

ES (1)