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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 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: June 14, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Coronary Artery Disease
Ischemic Heart Disease
Device: Drug-eluting stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of a Sirolimus Eluting ORSIRO Stent With a Biolimus-eluting NOBORI Stent in Patients Treated With Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 2314
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ORSIRO stent
ORSIRO stent group
Device: Drug-eluting stent
Other Names:
  • ORSIRO sirolimus-eluting stent
  • NOBORI biolimus-eluting stent
Active Comparator: NOBORI stent
NOBORI stent group
Device: Drug-eluting stent
Other Names:
  • ORSIRO sirolimus-eluting stent
  • NOBORI biolimus-eluting stent

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879358

Contacts
Contact: Lisette Okkels Jensen, MD DMSci PhD 004565412620 okkels@dadlnet.dk
Contact: Per Thayssen, MD DMSci 004565412681 per.thayssen@ouh.regionsyddanmark.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Lisette Okkels Jensen, MD DMSci PhD    004565412620    okkels@dadlnet.dk   
Contact: Per Thayssen, MD DMSci    004565412691    per.thayssen@ouh.regionsyddanmark.dk   
Principal Investigator: Lisette Okkels Jensen, MD DMSci PhD         
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Chair: Jens F Lassen, MD DMSci Aarhus University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Lisette Okkels Jensen, MD DMSci PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01879358     History of Changes
Other Study ID Numbers: SORT OUT VII, OUH
Study First Received: March 18, 2013
Last Updated: June 14, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Drug-eluting stent
Safety
Efficacy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014