Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent
NCT03952273 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3141
Last updated 2023-04-26
Summary
SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.
Conditions
Interventions
- COMBINATION_PRODUCT
-
PCI with BioMatrix Alpha™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
- COMBINATION_PRODUCT
-
PCI with Combo™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Sponsors & Collaborators
-
Aarhus University Hospital
collaborator OTHER -
Odense University Hospital
collaborator OTHER -
OrbusNeich
collaborator INDUSTRY -
Biosensors International
collaborator OTHER -
Phillip Freeman
lead OTHER
Principal Investigators
-
Phillip Freemann, MD · Aalborg University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-14
- Primary Completion
- 2023-03-19
- Completion
- 2030-11-30
Countries
- Denmark
Study Locations
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