The SORT OUT IX STEMI OCT Trial

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02915107

Acronym

OCT STEMI SOIX

Enrollment

Registered

2016-09-26

Start date

2016-09-30

Completion date

2023-09-30

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

drug eluting stents, coronary vascular healing

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.

Interventions

DEVICEBioFreedom

PCI with BioFreedom

DEVICEOrsiro

PCI with BioFreedom

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame
Target lesion failure	1 year, 2 years, 3 years, 4 years, 5 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026