ClinicalTrials.gov
ClinicalTrials.gov Menu

The SORT OUT IX STEMI OCT Trial (OCT STEMI SOIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02915107
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : January 18, 2017
Sponsor:
Collaborators:
Aarhus University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lisette Okkels Jensen, 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).

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: BioFreedom Device: Orsiro Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Biofreedom
Experimental: Biofreedom BioFreedom stent at index procedure
Device: BioFreedom
PCI with BioFreedom

Active Comparator: Orsiro
Active comparator: Orsiro Orsiro stent at index procedure
Device: Orsiro
PCI with BioFreedom




Primary Outcome Measures :
  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. [ Time Frame: Primary endpoint assessed after 1 month ]

Secondary Outcome Measures :
  1. Target lesion failure [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915107


Contacts
Contact: Lisette Okkels Jensen, MD DMSci PhD +4565412690 okkels@dadlnet.dk
Contact: Helle Cappelen, Study nurse +4565412690 helle.cappelen@rsyd.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8210
Contact: Evald Høj Christensen, MD PhD         
Principal Investigator: Evald Høj Christiansen, MD PhD         
Copenhagen University Hospital Not yet recruiting
Copenhagen, Denmark
Contact: Jens F Lassen, MD PhD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Lisette Okkels Jensen, MD DMSci PhD    004565412620    okkels@dadlnet.dk   
Principal Investigator: Lisette Okkels Jensen, MD DMSci PhD         
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Investigators
Principal Investigator: Lisette Okkels Jensen, MD DMSci PhD Odense University Hospital

Responsible Party: Lisette Okkels Jensen, MD DMSci, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02915107     History of Changes
Other Study ID Numbers: SO IX OCT STEMI
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Lisette Okkels Jensen, Odense University Hospital:
drug eluting stents
coronary vascular healing

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases