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)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting Xience or Promus stents) in a population-based setting with coronary artery stenosis treated with percutaneous coronary intervention
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents
Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Lisette O Jensen, MD
lisette.okkels.jensen@rsyd.dk
+4565412690
Time Frame
Start Date: 2024-11-16
Estimated Completion Date: 2032-07-01
Participants
Target number of participants: 3150
Treatments
Experimental: Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent
Percutaneous coronary interventin with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent
Active_comparator: Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent)
Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent)
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital