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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

June 4, 2012
October 6, 2013
March 2011
July 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01956448 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity®
Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*

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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Angina Pectoris
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 (BioMatrix Flex)
    Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex)
    Intervention: Device: Drug eluting stent
  • Experimental: Drug eluting stent (Resolute Integrity)
    Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
    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.
 
Completed
2800
July 2012
July 2012   (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.

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01956448
M-20110037
Yes
Evald Hoej Christiansen, Aarhus University Hospital Skejby
Aarhus University Hospital Skejby
  • Biosensors International
  • Medtronic Cardiovascular
Principal Investigator: Jan Ravkilde, MD Aalborg Universitetshospital
Aarhus University Hospital Skejby
October 2013

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