Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aarhus University Hospital Skejby | OTHER |
| Aalborg University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using registry detection of clinically driven events
SORT OUT IX is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in treating atherosclerotic coronary artery lesions.
Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. Block randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign patients in a 1:1 ratio to receive the polymer-free Biolimus-eluting BIOFREEDOM stent (Biosensors) or the biodegradable-polymer Sirolimus-eluting ORSIRO stent (Biotronik). A web based Trial Partner randomization system will be used.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofreedom | Experimental | Biofreedom stent treatment at index procedure |
|
| Orsiro | Active Comparator | Orsiro stent treatment at index procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofreedom | Device | PCI with Biofreedom stent |
| |
| Orsiro |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure | Primary endpoint assessed after 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | Target lesion failure will be assessed yearly up to 5 years after index procedure | 2 year, 3 year, 4 year, 5 year |
| Stent thrombosis | Stent thrombosis will be assessed yearly up to 5 years after index procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisette Okkels Jensen, MD DMSci PhD | Odense University Hospital | Study Chair |
| Evald H Christiansen, MD PhD | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32434381 | Derived | Jensen Lisette Okkels, Maeng M, Raungaard B, Kahlert J, Ellert J, Jakobsen L, Villadsen AB, Veien KT, Kristensen SD, Ahlehoff O, Carstensen S, Christensen MK, Terkelsen CJ, Engstroem T, Hansen KN, Botker HE, Aaroe J, Thim T, Thuesen L, Freeman P, Aziz A, Eftekhari A, Junker A, Jensen SE, Lassen JF, Hansen HS, Christiansen EH; Sort Out IX Study Group. Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial. Circulation. 2020 Jun 23;141(25):2052-2063. doi: 10.1161/CIRCULATIONAHA.119.040241. Epub 2020 May 21. | |
| 31055192 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
PCI with Orsiro stent |
|
| 1 year, 2 years, 3 years, 4 years, 5 years |
| Myocardial infarction | Myocardial infarction will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years |
| Cardiac death | Cardiac death will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years |
| All cause mortality | All cause mortality will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years |
| Target lesion revascularization | Target lesion revascularization will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years |
| Target vessel revascularization | Target vessel revascularization will be assessed yearly up to 5 years after | 1 year, 2 years, 3 years, 4 years, 5 years |
| Derived |
| Jensen LO, Maeng M, Raungaard B, Engstrom T, Hansen HS, Jensen SE, Botker HE, Kahlert J, Lassen JF, Christiansen EH. Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the randomized SORT OUT IX trial. Am Heart J. 2019 Jul;213:1-7. doi: 10.1016/j.ahj.2019.02.017. Epub 2019 Mar 14. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |