NCT02915107

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 22, 2016

Last Update Submit

September 17, 2020

Conditions

Acute Myocardial Infarction

Keywords

drug eluting stentscoronary vascular healing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Target lesion failure

    1 year, 2 years, 3 years, 4 years, 5 years

Study Arms (2)

Biofreedom

EXPERIMENTAL

Experimental: Biofreedom BioFreedom stent at index procedure

Device: BioFreedom

Orsiro

ACTIVE COMPARATOR

Active comparator: Orsiro Orsiro stent at index procedure

Device: Orsiro

Interventions

BioFreedomDEVICE

PCI with BioFreedom

Biofreedom
OrsiroDEVICE

PCI with BioFreedom

Orsiro

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Aarhus, 8210, Denmark

Location

Copenhagen University Hospital

Copenhagen, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34985003DERIVED

Study Officials

  • Lisette Okkels Jensen, MD DMSci PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD DMSci

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 26, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2023

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations

DK(3)