Coronary Laser in Undilatable or Uncrossable Lesions (LUDICO)
LUDICO Study: Effectiveness and Safety of Coronary Laser in UnDIlatable or unCrOssable Lesions
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Madrid
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Madrid, Madrid, Spain
- Hospital Universitario La Paz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
undilatable lesions
expansion <80% of the distal vessel diameter after inflation of a 1:1 non-compliant balloon at 18 atm
|
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
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Laser Success
Time Frame: 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.
|
From enrollment to the end of the procedure at 4 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Angiographic success
Time Frame: From enrollment to the end of the procedure at 4 hours.
|
Thrombolysis in myocardial infarction (TIMI) 3 final flow and a diameter stenosis <20%.
|
From enrollment to the end of the procedure at 4 hours.
|
|
Procedural success
Time Frame: 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).
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From enrollment to the end of the procedure at 4 hours.
|
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Intracoronary imaging-based success
Time Frame: 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.
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From enrollment to the end of the procedure at 4 hours.
|
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Events at 1 year
Time Frame: From enrollment to 1 year after the procedure
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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.
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From enrollment to 1 year after the procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5502
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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