RecruitingNCT06863155

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

Sponsor

Fundación EPIC

Enrollment

500 participants

Start Date

May 6, 2025

Study Type

OBSERVATIONAL

Conditions

Coronary Artery Disease Ischemic Heart Disease

Summary

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria7

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.

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