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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
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The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).
SORT OUT IX STEMI OCT is a randomized 1:1 study comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent patients with STEMI treated with primary PCI.
Vascular healing index (uncovered stent struts, malapposed stent struts, maximal intima coverage and accumulated extra-stent lumen volume) assessed with optical coherence tomography (OCT) 1 month after primary PCI.
Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before primary PCI. A web based Trial Partner randomization system will be used.
OCT will be performed with the frequency-domain OPTIS OCT system and Dragonflyâ„¢ Imaging Catheter during the index procedure and after 1 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofreedom | Experimental | Experimental: Biofreedom BioFreedom stent at index procedure |
|
| Orsiro | Active Comparator | Active comparator: Orsiro Orsiro stent at index procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioFreedom | Device | PCI with BioFreedom |
| |
| Orsiro |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular healing index (uncovered stent struts, malapposed stent struts, maximal intima coverage and accumulated extra-stent lumen volume) assessed with optical coherence tomography (OCT) 1 month after primary PCI. | Primary endpoint assessed after 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | 1 year, 2 years, 3 years, 4 years, 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisette Okkels Jensen, MD DMSci PhD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8210 | Denmark | |||
| Copenhagen University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34985003 | Derived | Hansen KN, Maeng M, Antonsen L, Maehara A, Jakobsen L, Ellert J, Terkelsen CJ, Ahlehoff O, Thim T, Fallesen CO, Noori M, Veien KT, Jensen LO, Christiansen EH. Early vascular healing after implantation of the polymer-free biolimus-eluting stent or the ultrathin strut biodegradable polymer sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction. Coron Artery Dis. 2022 May 1;33(3):196-205. doi: 10.1097/MCA.0000000000001113. |
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| Device |
PCI with BioFreedom |
|
| Copenhagen |
| Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |