Comparing two types of drug-eluting stents for heart procedures
Official title: Randomized Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated With Percutaneous Coronary Intervention in an All Comer Population (The SORT OUT XII Trial)
Run by Odense University Hospital · NCT06692140 · Data updated 2026-11-12
This study is testing whether a new type of heart stent with a thinner design works better and is safer than a traditional stent for patients with blocked arteries.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3150 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 3 sites (Aalborg and 2 other locations) |
| Status | Recruiting |
| Started | November 16, 2024 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2032 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT06692140 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who require treatment with drug-eluting coronary stents.
✕Probably not a fit
Patients who are under 18 years old, unable to consent, or have a life expectancy of less than one year 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 study aims to evaluate the safety and effectiveness of an ultra-low strut thickness everolimus-eluting biodegradable polymer stent against traditional durable polymer everolimus-eluting stents in patients undergoing percutaneous coronary intervention for coronary artery disease. It is a randomized trial that includes patients with coronary artery stenosis to determine which stent type provides better outcomes. The study will assess various clinical endpoints to establish the superiority of one stent over the other in a real-world setting.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with coronary artery disease, potentially reducing complications and enhancing recovery.
How similar studies have gone: Previous studies have shown promising results with drug-eluting stents, but this specific comparison of biodegradable versus durable polymer stents is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents Exclusion Criteria: * Age \< 18 years * Not able to consent to study participating (eg. intubated patients) * Unstable circuit or in cardiogenic shock and therefore not able to understand the information and purpose of the study * Do not speak Danish * Already included in the SORT OUT XII study * Life expectancy \<1 year * Allergic to study related treatment
Where it's running
-
Aalborg University Hospital
Aalborg, Denmark Recruiting -
Aarhus University Hospital
Aarhus, Denmark Recruiting -
Odense University Hospital
Odense, Denmark Recruiting
Study contacts
- Principal investigator: Lisette O Jensen — Odense University Hospital
- Study coordinator: Lisette O Jensen, MD
- Email: lisette.okkels.jensen@rsyd.dk
- Phone: +4565412690
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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.