Ultrathin strut stent for patients on blood thinners
Official title: Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
Run by Fundación EPIC · NCT06863155 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 13 sites (Albacete and 12 other locations) |
| Status | Recruiting |
| Started | May 6, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2029 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06863155 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise with similar ultrathin strut stents, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
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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
Show 7 more locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain Recruiting -
Hospital Universitario de Canarias
Laguna, Spain Recruiting -
Hospital Doctor Jose Molina Orosa
Las Palmas de Gran Canaria, Spain Recruiting -
Hospital Universitario Puerta de Hierro
Majadahonda, Spain Recruiting -
Hospital Universitario de Navarra
Pamplona, Spain Recruiting -
Hospital General de Fuerteventura
Puerto del Rosario, 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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QFR-guided virtual stenting to optimize PCI before the procedure
We’re testing whether using QFR-based virtual stenting before PCI can improve heart-procedure outcomes compared with standard angiography planning in adults with coronary artery disease.
-
LONG NAGOMI PMCF: follow-up of the Ultimaster Nagomi stent in long coronary artery lesions
This project tests the Ultimaster Nagomi drug-eluting stent in adults undergoing PCI for long coronary lesions to collect real-world safety and effectiveness data.
-
Coronary CT angiography versus standard follow-up after stent placement for high-risk patients
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Essential Pro paclitaxel‑eluting coronary balloon post-market follow-up (rEPIC04E-HK)
This project will follow people with coronary artery disease treated with the Essential Pro paclitaxel‑eluting coronary balloon to see if the device is safe and works well in routine care.
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This study tests whether different doses of adenosine can improve heart imaging for people suspected of having chronic coronary syndrome.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.