The SORT OUT IX STEMI OCT Trial

Not Applicable

• Conditions: Acute Myocardial Infarction
• Interventions: Device: Orsiro; Device: BioFreedom

• Registration Number: NCT02915107
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Primary Completion: 2018-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-21
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orsiro	Orsiro	Active comparator: Orsiro Orsiro stent at index procedure
Biofreedom	BioFreedom	Experimental: Biofreedom BioFreedom stent at index procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Target lesion failure	1 year, 2 years, 3 years, 4 years, 5 years

Trial Locations

Locations (3)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark