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

October 6, 2013 updated by: Evald Hoej Christiansen, Aarhus University Hospital Skejby

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

2800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
    • Aarhus N
      • Skejby, Aarhus N, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-related combined endpoint
Time Frame: 1,2,3 and 5 years

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.
1,2,3 and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause death
Time Frame: 10 years
10 years
Device success rate
Time Frame: 12 months
12 months
Procedure success rate
Time Frame: 12 months
12 months
Procedure time
Time Frame: 12 months
12 months
Fluoroscopy time
Time Frame: 12 months
12 months
Amount of contrast
Time Frame: 12 months
12 months
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
30 days
Target lesion revascularisation
Time Frame: 1,2,3 and 5 years
1,2,3 and 5 years
Death and myocardial infarction
Time Frame: 1 and 12 months
1 and 12 months
Stent thrombosis
Time Frame: 1,2,3 and 5 years
1,2,3 and 5 years
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
2,3 and 5 years
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
1,2,3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Collaborators

Medtronic Cardiovascular
Biosensors International

Investigators

  • Principal Investigator: Jan Ravkilde, MD, Aalborg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

October 6, 2013

First Posted (ESTIMATE)

October 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 6, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20110037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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