NCT07206082Active, not recruiting
Coronary Laser in Undilatable or Uncrossable Lesions
LUDICO Study: Effectiveness and Safety of Coronary Laser in UnDIlatable or unCrOssable Lesions
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 230 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 5 Jun 2020
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- Hospital Universitario La Paz
- Diseases
- Coronary artery disease
- NCT number
- NCT07206082
What you commit to
- Study type: Observational
- Planned participants: 230
- From 5 Jun 2020 to the primary completion date, 10 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with known allergies to aspirin (ASA), clopidogrel, prasugrel, or ticagrelor.
Lab values
- 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.
Other
- Patients unable to provide informed consent, either personally or through a legal representative.
- Patients with significant comorbidities and a life expectancy of less than one year.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.