Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic … (NCT06863155) | Clinical Trial Compass
RecruitingNot Applicable
Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
Spain500 participantsStarted 2025-05-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an ultrathin strut sirolimus-eluting stent with a bioabsorbable polymer specifically in patients who take chronic oral anticoagulation — since I'm already on a blood thinner, how does being on that medication long-term affect my risk of bleeding or clotting complications if I were to receive this type of stent?
2The trial is measuring something called 'Net Adverse Clinical Events' — can you explain what events are included in that outcome measure and what that means for understanding both the risks and potential benefits I'd need to weigh?
3This trial is listed as Phase NA, which often applies to device studies rather than drug trials — does that change what we already know about the safety profile of this stent design compared to a Phase 1 or Phase 2 drug trial?
4Given that this study is actively recruiting, would you expect enough data to be available soon to help guide my own treatment decision, or would standard stenting options already supported by existing evidence be a more appropriate path for me right now?
5Since this trial involves a specific combination of ultrathin struts and a bioabsorbable polymer, what is it about that design that might matter for someone in my situation who needs ongoing anticoagulation, and are there currently approved stents that work similarly that I could consider outside of a trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.