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Recruiting NCT06863155

Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation

Conditions: Coronary Artery Disease Ischemic Heart Disease

Sponsor: Fundación EPIC

trial.available_in: БГ
Overview
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
Description
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
Who can participate
Inclusion Criteria: Patients must meet all inclusion criteria: * Patients with Signed informed consent and * Patients with \>=18 years old and * Patients with chronically receiving oral anticoagulation treatment with any type of anticoagulant for any reason and * Patients with de novo Coronary artery disease requiring both elective or urgent percutaneous revascularization due to stable coronary artery disease or acute coronary syndrome with or without ST-segment elevation, and in which an ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer has been used Exclusion Criteria: Patients do not have to meet any exclusion criteria * Patients treated percutaneously with any type of stent other than the SupraFlex Cruz® in the 6 months prior to the index procedure in which he or she is included. * Use in the same procedure or in a scheduled procedure of other stents different from the one evaluated for the treatment of another vessel(s). * Patients treatment for restenosis or stent thrombosis. * Patients presentation in cardiogenic shock or after cardiorespiratory arrest. * Patients with allergy to any of the components of the stent to be used. * Patients with impossibility for follow-up. * Patients with life expectancy less than 1 year.
Interventions
Supraflex Cruz Sirolimus-eluting Stent
DEVICE
Locations 10
Spain (10)
Hospital General Universitario de Albacete
Albacete
Hospital Universitario San Juan de Alicante
Alicante
Hospital General Universitario de Merida
Badajoz
Hospital General Universitari de Castelló
Castelló
H.G.U. de Ciudad Real.
Ciudad Real
Hospital General Universitari d'Elx
Elche
Hospital Universitario de Canarias
Laguna
Hospital Universitario Puerta de Hierro
Majadahonda
Hospital Universitario de Navarra
Pamplona
Hospital Clinico Universitario Lozano Blesa
Zaragoza
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.05.2025
Completion date
31.03.2029
Registry ID
NCT06863155
Source
clinicaltrials.gov
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