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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.
Hospital General Universitario de Albacete
Albacete, Spain
RECRUITINGHospital Universitario San Juan de Alicante
Alicante, Spain
RECRUITINGHospital General Universitario de Merida
Badajoz, Spain
NACE (Net Adverse Clinical Events)
Combined endpoint of Cardiac Death, Acute Myocardial Infarction, Stroke, Need for new Treated Vessel Revascularization (TVR) and BARC (Bleeding Academic Research Consortium) 3-5
Time frame: 12 month
MACE (Major Adverse Cardiac Events)
To assess the occurrence of major adverse cardiac events (MACE) in patients receiving chronic oral anticoagulation who have been treated with ultrathin strut Sirolimus-eluting stents with bioabsorbable polymer.
Time frame: 12 months
MACE (Major Adverse Cardiac Events)
To assess the occurrence of major adverse cardiac events (MACE) in patients receiving chronic oral anticoagulation who have been treated with ultrathin strut Sirolimus-eluting stents with bioabsorbable polymer.
Time frame: 6 months
TLF (Target Lesion Failure)
To assess the failure rate of the lesion treated (TLF) with ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer in patients receiving chronic oral anticoagulation.
Time frame: 12 months
TLF (Target Lesion Failure)
To assess the failure rate of the lesion treated (TLF) with ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer in patients receiving chronic oral anticoagulation.
Time frame: 6 months
Death
To assess the occurrence of Death
Time frame: 12 months
Death
To assess the occurrence of Death
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Hospital General Universitari de Castelló
Castelló, Spain
RECRUITINGH.G.U. de Ciudad Real.
Ciudad Real, Spain
RECRUITINGHospital General Universitari d'Elx
Elche, Spain
RECRUITINGHospital Universitario Puerta de Hierro
Majadahonda, Spain
RECRUITINGHospital Clinico Universitario Lozano Blesa
Zaragoza, Spain
RECRUITINGTime frame: 6 months
Acute Myocardial Infarction (AMI)
To assess the occurrence of AMI
Time frame: 12 months
Acute Myocardial Infarction (AMI)
To assess the occurrence of AMI
Time frame: 6 months
Stroke
To assess the occurrence of Stroke
Time frame: 12 months
Stroke
To assess the occurrence of Stroke
Time frame: 6 months
Target vessel revascularization (TVR)
To assess the occurrence of TVR
Time frame: 12 months
Target vessel revascularization (TVR)
To assess the occurrence of TVR
Time frame: 6 months