Ultrathin strut stent for patients on blood thinners
Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
This study is testing a new type of stent for patients on blood thinners to see if it can safely reduce the time they need to take additional blood-thinning medication after heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 10 sites (Albacete and 9 other locations) |
| Trial ID | NCT06863155 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who are on chronic oral anticoagulation and require percutaneous coronary revascularization with stent implantation. It evaluates the use of a new generation ultrathin strut sirolimus-eluting stent with a bioabsorbable polymer, which may allow for shorter antiplatelet therapy regimens. The study aims to assess the safety and efficacy of this stent in high-bleeding risk patients, potentially improving their treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are chronically receiving oral anticoagulation and have de novo coronary artery disease requiring stent implantation.
Not a fit: Patients who have been treated with any type of stent other than the SupraFlex Cruz® in the past 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce bleeding risks and improve recovery for patients requiring stenting while on anticoagulants.
How similar studies have performed: Other studies have shown promise with similar ultrathin strut stents, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Albacete and 9 other locations
- Hospital General Universitario de Albacete — Albacete, Spain (Recruiting)
- Hospital Universitario San Juan de Alicante — Alicante, Spain (Recruiting)
- Hospital General Universitario de Merida — Badajoz, Spain (Recruiting)
- Hospital General Universitari de Castelló — Castelló, Spain (Recruiting)
- H.G.U. de Ciudad Real. — Ciudad Real, Spain (Recruiting)
- Hospital General Universitari d'Elx — Elche, Spain (Recruiting)
- Hospital Universitario de Canarias — Laguna, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Majadahonda, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Spain (Recruiting)
- Hospital Clinico Universitario Lozano Blesa — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Juan Gabriel Córdoba Soriano, MD, PhD
- Email: jgcordoba@foroepic.org
- Phone: 0034 967597532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.