Actively Recruiting
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)
Led by Odense University Hospital · Updated on 2024-12-09
3150
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the safety and effectiveness of two types of everolimus-eluting stents used in patients with coronary artery stenosis treated with percutaneous coronary intervention (PCI). The study focuses on a new ultra-low strut thickness biodegradable polymer stent called Evermine50 and compares it with established durable polymer everolimus-eluting stents, Xience or Promus. This randomized study aims to evaluate these devices in a broad patient population undergoing PCI to improve treatment options for coronary artery disease and ischemia. Participants will receive either the ultra-low strut thickness biodegradable Evermine50 stent or one of the durable polymer everolimus-eluting stents (Xience or Promus) during their PCI procedure. The study involves two groups: one treated with the Evermine50 stent (experimental arm) and the other with the durable polymer stents (comparator arm). The interventions consist of placing these drug-eluting stents to open narrowed coronary arteries and restore blood flow. During the study, researchers will monitor participants for up to five years, focusing on key outcomes such as target lesion failure at one year, and tracking all-cause death, cardiac death, myocardial infarction, stent thrombosis, and repeat revascularization at one, three, and five years. Participants will undergo regular evaluations to assess the safety and effectiveness of the stents. The total duration of involvement varies, with follow-up visits scheduled over several years to gather comprehensive safety and efficacy data.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Eligible for treatment with one or more drug-eluting coronary stents
You will not qualify if you...
- Under 18 years of age
- Unable to consent to participation (e.g., intubated patients)
- Unstable circulation or cardiogenic shock preventing understanding of study information
- Do not speak Danish
- Already enrolled in the SORT OUT XII study
- Life expectancy less than 1 year
- Allergy to study-related treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo percutaneous coronary intervention with either an ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent or a durable polymer everolimus-eluting Xience or Promus stent.
1 procedure visit (in-person)
Duration - Up to 5 years
Participants are monitored for up to 5 years to assess outcomes such as target lesion failure, cardiac events, and stent-related complications.
Follow-up visits at 1 year, 3 years, and 5 years
Trial Site Locations
Total: 3 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
3
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
L
Lisette O Jensen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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