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Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent (SORT OUT VII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Lisette Okkels Jensen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01879358
First received: March 18, 2013
Last updated: September 9, 2014
Last verified: September 2014

March 18, 2013
September 9, 2014
November 2012
January 2014   (final data collection date for primary outcome measure)
Cardiac death, myocardial infarction or target lesion revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization)
Same as current
Complete list of historical versions of study NCT01879358 on ClinicalTrials.gov Archive Site
Cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization, all cause mortality, stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Cardiac mortality Myocardial infarction Target lesion revascularization Target vessel revascularization All cause mortality Stent thrombosis rate according to the Academic Research Consortium definition Secondary endpoints will be assessed after 1 year, 2 years, 3 years, 4 years and 5 years.
Same as current
Not Provided
Not Provided
 
Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent
Randomized Comparison of a Sirolimus Eluting ORSIRO Stent With a Biolimus-eluting NOBORI Stent in Patients Treated With Percutaneous Coronary Intervention

The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the biolimus-eluting NOBORI stent in a population-based setting, using registry detection of clinically driven events

SORT OUT VII is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the sirolimus eluting ORSIRO stent to the biolimus-eluting NOBORI stent in treating atherosclerotic coronary artery lesions.

Primary Endpoint:

Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).

Secondary Endpoints:

Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).

Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death

Inclusion criteria:

at least 18 years old chronic stable coronary artery disease or acute coronary syndromes at least one coronary artery lesion with more than 50% diameter stenosis requiring treatment with a drug-eluting stent

Exclusion criteria:

life expectancy of less than one year allergy to aspirin, clopidogrel, sirolimus, or biolimus participation in another randomized trial nability to provide written informed consent

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Ischemic Heart Disease
Device: Drug-eluting stent
Other Names:
  • ORSIRO sirolimus-eluting stent
  • NOBORI biolimus-eluting stent
  • Active Comparator: ORSIRO stent
    ORSIRO stent group
    Intervention: Device: Drug-eluting stent
  • Active Comparator: NOBORI stent
    NOBORI stent group
    Intervention: Device: Drug-eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2314
January 2015
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent. There are no restrictions on number of treated lesions, number of treated vessels, or lesion length.

Exclusion Criteria:

  • Exclusion criteria are life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, sirolimus, or biolimus; participation in another randomized trial; or inability to provide written informed consent
Both
Not Provided
No
Contact: Lisette Okkels Jensen, MD DMSci PhD 004565412620 okkels@dadlnet.dk
Contact: Per Thayssen, MD DMSci 004565412681 per.thayssen@ouh.regionsyddanmark.dk
Denmark
 
NCT01879358
SORT OUT VII, OUH
Yes
Lisette Okkels Jensen, Odense University Hospital
Odense University Hospital
Not Provided
Study Chair: Jens F Lassen, MD DMSci Aarhus University Hospital
Odense University Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP