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

Fundación EPIC

Status: Enrolling

Conditions: Ischemic Heart Disease; Coronary Artery Disease

Treatments: Device: Supraflex Cruz Sirolimus-eluting Stent

Study type: Observational

Funder types: Other

Identifiers

NCT06863155

rEPIC13-ACO-FLEX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Supraflex Cruz Sirolimus-eluting Stent

Treatment:

Device: Supraflex Cruz Sirolimus-eluting Stent