Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2016-09-30
2023-09-30
Brief Summary
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Detailed Description
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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 Dragonfly™ Imaging Catheter during the index procedure and after 1 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Biofreedom
Experimental: Biofreedom BioFreedom stent at index procedure
BioFreedom
PCI with BioFreedom
Orsiro
Active comparator: Orsiro Orsiro stent at index procedure
Orsiro
PCI with BioFreedom
Interventions
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BioFreedom
PCI with BioFreedom
Orsiro
PCI with BioFreedom
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Lisette Okkels Jensen
MD DMSci
Principal Investigators
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Lisette Okkels Jensen, MD DMSci PhD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Copenhagen University Hospital
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
Other Identifiers
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SO IX OCT STEMI
Identifier Type: -
Identifier Source: org_study_id
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