Status:
COMPLETED
Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent
Lead Sponsor:
Fundación EPIC
Conditions:
Cardiovascular Diseases
Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. The laser-excimer technology achieves a grea...
Detailed Description
The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. The investigators propose a study that serv...
Eligibility Criteria
Inclusion
- Patients with:
- Age ≥ 18 years.
- Consecutive real-world patients, referred for cardiac catheterization for any cause, who present in any main vessel, bypass or in the common trunk an under-expanded stent tributary of being treated (minimum luminal area \<4 mm2 or \<6 mm2 in the left main coronary artery measured by IVUs (Intravascular Ultrasound) / OCT(Optical Coherence Tomography)) and that it is not possible to dilate with a NC balloon to a maximum of 20 atm.
Exclusion
- Refusal of the patient to participate in the study.
- Patients with life expectancy \<1 year.
- Patients with advanced kidney disease (grade IV) or liver failure (Child C)
Key Trial Info
Start Date :
September 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04359446
Start Date
September 12 2020
End Date
June 28 2023
Last Update
August 8 2023
Active Locations (6)
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1
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Coruña, Spain, 15706
2
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
3
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
4
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain, 21005