Supraflex Cruz Sirolimus-eluting Stent
DevicePCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.
NCT Number: NCT06863155
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hospital General Universitario de Albacete, Albacete, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients must meet all inclusion criteria:
Exclusion criteria
Patients do not have to meet any exclusion criteria
PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.
Time frame: 12 month
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 months
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
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
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
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
To assess the occurrence of Death
Time frame: 6 months
To assess the occurrence of Death
Time frame: 12 months
To assess the occurrence of AMI
Time frame: 6 months
To assess the occurrence of AMI
Time frame: 12 months
To assess the occurrence of Stroke
Time frame: 6 months
To assess the occurrence of Stroke
Time frame: 12 months
To assess the occurrence of TVR
Time frame: 6 months
To assess the occurrence of TVR
Contact information is provided by the study sponsor or research team.
FUNDACION EPIC
CONTACT
Juan Gabriel Córdoba Soriano, MD, PhD
CONTACT
Fundación EPIC
Other
Acronym: ACO_FLEX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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