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

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

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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.

Study details
    Coronary Artery Disease
    Ischemic Heart Disease

NCT06863155

Fundación EPIC

28 July 2025

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