Coronary Artery DiseaseLUDICONCT07206082
Coronary Laser in Undilatable or Uncrossable Lesions
An observational study of Coronary Artery Disease and Calcified Coronary Artery Disease, run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Calcified Coronary Artery Disease, In Stent Restenosis
- What is being tested?
- Laser atherectomy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 230 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2020to 20 Oct 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication for PCI and undilatable or uncrossable lesions treated with ELCA
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LUDICO Study: Effectiveness and Safety of Coronary Laser in UnDIlatable or unCrOssable Lesions
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)
- Being tested
- Laser atherectomy
- Keywords
- Percutaneous coronary intervention, excimer laser coronary atherectomy, intravascular imaging, optical coherence tomography, complex coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser atherectomyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| undilatable lesions | expansion <80% of the distal vessel diameter after inflation of a 1:1 non-compliant balloon at 18 atm Receives: Device: Laser atherectomy | |
| uncrossable coronary lesions | (not crossable after using a small-profile balloon with adequate support, according to operator´s discretion Receives: Device: Laser atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the procedure at 4 hours.
Secondary outcomes (4)
Angiographic success
Thrombolysis in myocardial infarction (TIMI) 3 final flow and a diameter stenosis <20%.
Measured: From enrollment to the end of the procedure at 4 hours.
Procedural success
Angiographic success without severe procedural complications (death, coronary perforation, abrupt vessel closure, flow-limiting dissection).
Measured: From enrollment to the end of the procedure at 4 hours.
Intracoronary imaging-based success
Stent expansion ≥80% [OCT or intravascular ultrasound (IVUS)] or a minimal stent area (MSA) ≥4.5mm2 in OCT or ≥5.5mm2 in IVUS.
Measured: From enrollment to the end of the procedure at 4 hours.
Events at 1 year
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.
Measured: From enrollment to 1 year after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start5 Jun 2020
- Primary completion10 Mar 2025
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Jurado, MD, PhD, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206082
- Sponsor's protocol ID
- 5502
- Acronym
- LUDICO
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be publicly shared; however, data sharing may be considered in selected cases upon reasonable request and with sufficient justification.
Publications
Jurado-Roman A, Zubiaur J, Basile M, Galeote G, Jimenez-Valero S, Suarez de Lezo J, Hidalgo F, Gallo I, Cid-Alvarez AB, Bellera N, Garcia Del Blanco B, Santana BR, Tebar D, Gonzalvez A, Moreno R. Design of the LUDICO study: effectiveness and safety of coronary laser in undilatable or uncrossable lesions. REC Interv Cardiol. 2026 Jan 22;8(3):152-160. doi: 10.24875/RECICE.M25000560. eCollection 2026 Jul-Sep.
PubMed 42723726
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUDICO Study: Effectiveness and Safety of Coronary Laser in UnDIlatable or unCrOssable Lesions
- ClinicalTrials.gov ID
- NCT07206082
- Acronym / sponsor ID
- LUDICO / 5502
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| undilatable lesions | – | Device: Laser atherectomyexpansion <80% of the distal vessel diameter after inflation of a 1:1 non-compliant balloon at 18 atm |
| uncrossable coronary lesions | – | Device: Laser atherectomy(not crossable after using a small-profile balloon with adequate support, according to operator´s discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for PCI and undilatable or uncrossable lesions treated with ELCA
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser atherectomyELCA 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 | Device | uncrossable coronary lesions, undilatable lesions |
Primary outcome
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.
4 secondary outcomes
Angiographic success
Time frame: 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.
Intracoronary imaging-based success
Time frame: From enrollment to the end of the procedure at 4 hours.
Events at 1 year
Time frame: From enrollment to 1 year after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 42723726Jurado-Roman A, Zubiaur J, Basile M, Galeote G, Jimenez-Valero S, Suarez de Lezo J, Hidalgo F, Gallo I, Cid-Alvarez AB, Bellera N, Garcia Del Blanco B, Santana BR, Tebar D, Gonzalvez A, Moreno R. Design of the LUDICO study: effectiveness and safety of coronary laser in undilatable or uncrossable lesions. REC Interv Cardiol. 2026 Jan 22;8(3):152-160. doi: 10.24875/RECICE.M25000560. eCollection 2026 Jul-Sep.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be publicly shared; however, data sharing may be considered in selected cases upon reasonable request and with sufficient justification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Calcified Coronary Artery Disease, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser Success (time frame: From enrollment to the end of the procedure at 4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07206082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.