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

Recruiting now

Conditions studied: Coronary Artery Disease, Ischemic Heart Disease

In brief

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.

Key facts

Study ID

NCT06863155

Run by

Fundación EPIC

People needed

500

Starts

2025-05-06

Expected to finish

2029-03-31

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hospital General Universitario de Albacete — Albacete, Spain (enrolling)
• Hospital Universitario San Juan de Alicante — Alicante, Spain (enrolling)
• Hospital General Universitario de Merida — Badajoz, Spain (enrolling)
• Hospital General Universitari de Castelló — Castelló, Spain (enrolling)
• H.G.U. de Ciudad Real. — Ciudad Real, Spain (enrolling)
• Hospital General Universitari d'Elx — Elche, Spain (enrolling)
• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Spain (enrolling)
• Hospital Universitario de Canarias — Laguna, Spain (enrolling)
• Hospital Doctor Jose Molina Orosa — Las Palmas de Gran Canaria, Spain (enrolling)
• Hospital Universitario Puerta de Hierro — Majadahonda, Spain (enrolling)
• Hospital Universitario de Navarra — Pamplona, Spain (enrolling)
• Hospital General de Fuerteventura — Puerto del Rosario, Spain (enrolling)
• Hospital Clinico Universitario Lozano Blesa — Zaragoza, Spain (enrolling)

Full record on ClinicalTrials.gov

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