SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® (SO VI)

This study has been completed.
Sponsor:
Collaborators:
Biosensors International
Medtronic Cardiovascular
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT01956448
First received: June 4, 2012
Last updated: October 6, 2013
Last verified: October 2013
  Purpose

To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.


Condition Intervention
Coronary Artery Disease
Angina Pectoris
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 Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Device-related combined endpoint [ Time Frame: 1,2,3 and 5 years ] [ Designated as safety issue: Yes ]

    Device-related combined endpoint hierarchically:

    cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months.



Secondary Outcome Measures:
  • Device success rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Procedure success rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Procedure time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Amount of contrast [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Target lesion revascularisation [ Time Frame: 1,2,3 and 5 years ] [ Designated as safety issue: Yes ]
  • Death and myocardial infarction [ Time Frame: 1 and 12 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1,2,3 and 5 years ] [ Designated as safety issue: Yes ]
  • Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion [ Time Frame: 2,3 and 5 years ] [ Designated as safety issue: Yes ]
  • Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations [ Time Frame: 1,2,3 and 5 years ] [ Designated as safety issue: Yes ]
  • All-cause death [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 2800
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug eluting stent (BioMatrix Flex)
Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex)
Device: Drug eluting stent
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Other Names:
  • BioMatrix Flex - biolimus eluting stent
  • Resolute - zotarolimus eluting stent
Experimental: Drug eluting stent (Resolute Integrity)
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Device: Drug eluting stent
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Other Names:
  • BioMatrix Flex - biolimus eluting stent
  • Resolute - zotarolimus eluting stent

Detailed Description:

SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of 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

  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.

Exclusion Criteria:

  • life expectancy of less than one year
  • an allergy to aspirin, clopidogrel, ticagrelor, prasugrel, sirolimus, or biolimus
  • participation in another randomized trial
  • 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: NCT01956448

Locations
Denmark
Aarhus University Hospital
Skejby, Aarhus N, Denmark, 8200
Aalborg University Hospital
Aalborg, Denmark, 9000
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Aarhus University Hospital Skejby
Biosensors International
Medtronic Cardiovascular
Investigators
Principal Investigator: Jan Ravkilde, MD Aalborg Universityhospital
  More Information

No publications provided

Responsible Party: Evald Hoej Christiansen, MD, DMSc, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01956448     History of Changes
Other Study ID Numbers: M-20110037
Study First Received: June 4, 2012
Last Updated: October 6, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital Skejby:
Percutaneous coronary intervention
DES
Angina pectoris
Stent

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 20, 2014