Clinical trial NCT02915107: The SORT OUT IX STEMI OCT Trial
Official title: Randomized Comparison of Vascular Healing of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients With ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: drug eluting stents
coronary vascular healing
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Rigshospitalet, Denmark
First posted: 2016-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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 Dragonfly™ Imaging Catheter during the index procedure and after 1 months.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or over with STEMI, requiring treatment with a drug-eluting stent.

Exclusion Criteria:

* life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; chronic renal disease; or inability to provide written informed consent.

Primary outcomes:
measure: 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.
timeFrame: Primary endpoint assessed after 1 month
Secondary outcomes:
measure: Target lesion failure
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Lisette Okkels Jensen, MD DMSci PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.