Status:
ACTIVE_NOT_RECRUITING
Coronary Laser in Undilatable or Uncrossable Lesions
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Coronary Artery Disease
Calcified Coronary Artery Disease
Eligibility:
All Genders
18+ years
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% a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 20 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT07206082
Start Date
June 5 2020
End Date
October 20 2025
Last Update
October 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario La Paz
Madrid, Madrid, Spain