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

Launched by FUNDACIÓN EPIC · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of heart stent called an ultrathin strut sirolimus-eluting stent, designed to help patients with coronary artery disease who are also taking blood thinners. These patients often face a higher risk of bleeding, so the goal of the trial is to see if this new stent can allow for shorter periods of taking additional blood-thinning medications, known as antiplatelet therapy, while still ensuring their safety and health.

To participate in the trial, patients must be at least 18 years old and currently on blood-thinning medication for any reason. They should also have coronary artery disease that requires a stent to be placed, either for ongoing heart issues or a recent heart-related event. Participants will receive the new stent and will be monitored to assess how well it works and how they respond to the treatment. It's important to know that this trial is not yet recruiting patients, but it offers a potential new option for those at high risk of bleeding who need stenting procedures.

Gender

ALL

Eligibility criteria

• 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.