The SORT OUT IX STEMI OCT Trial

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: BioFreedom
* Device: Orsiro


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofreedom<br>Experimental: Biofreedom BioFreedom stent at index procedure | Device: BioFreedom<br>* PCI with BioFreedom<br>|
| Active Comparator: Orsiro<br>Active comparator: Orsiro Orsiro stent at index procedure | Device: Orsiro<br>* PCI with BioFreedom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure |  | 1 year, 2 years, 3 years, 4 years, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stents, coronary vascular healing