NCT06863155 Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
| NCT ID | NCT06863155 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-05-06 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06863155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06863155 currently recruiting?
Yes, NCT06863155 is actively recruiting participants. Contact the research team at jgcordoba@foroepic.org for enrollment information.
Where is the NCT06863155 trial being conducted?
This trial is being conducted at Albacete, Spain, Alicante, Spain, Badajoz, Spain, Castelló, Spain and 6 additional locations.
Who is sponsoring the NCT06863155 clinical trial?
NCT06863155 is sponsored by Fundación EPIC. The trial plans to enroll 500 participants.