Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Everolimus-eluting SYNERGY Stent Versus Biolimus-eluting Biomatrix NeoFlex Stent - SORT-OUT VIII (SORT-OUT VIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02093845
Recruitment Status : Active, not recruiting
First Posted : March 21, 2014
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
Boston Scientific Corporation
Biosensors Europe SA
Information provided by (Responsible Party):
Michael Mæng, Aarhus University Hospital Skejby

Brief Summary:
The purpose of this study is to perform a randomised comparison between the SYNERGY and the Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Ischemic Heart Disease Device: Biomatrix NeoFlex coronary stent Device: SYNERGY stent Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparison of Everolimus-Eluting SYNERGY® and Biolimus-Eluting BioMatrix NeoFlex® Coronary Stents in Non-Selected Patients With Ischemic Heart Disease
Actual Study Start Date : February 10, 2014
Actual Primary Completion Date : August 24, 2015
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SYNERGY
Coronary implantatation of the SYNERGY everolimus-eluting stent
Device: SYNERGY stent
Percutaneous coronary intervention involving use of stent
Other Name: Everolimus-eluting SYNERGY coronary stent

Active Comparator: Biomatrix Neoflex
Coronary implantation of the biolimus-eluting Biomatrix NeoFlex stent
Device: Biomatrix NeoFlex coronary stent
Percutaneous coronary intervention involving use of stent
Other Name: Biolimus-eluting Biomatrix NeoFlex coronary stent




Primary Outcome Measures :
  1. Device-related target lesion failure [ Time Frame: 12 months ]
    Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation (significant stenosis in the stent =/+ 5 mm distal/proximal) by percutaneous coronary intervention or coronary artery bypass operation


Secondary Outcome Measures :
  1. Device-related target lesion failure [ Time Frame: 2, 3, 4 and 5 years ]
    Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation by percutaneous coronary intervention or coronary artery bypass operation

  2. Patient-related combined endpoint [ Time Frame: 1, 2, 3, 4 and 5 year ]
    Hierarchically as all-cause death, non-index procedure related acute myocardial infarction, or all new revascularisation by percutaneous coronary intervention or coronary artery bypass operation

  3. Individual above mentioned stent- or patient-related endpoints [ Time Frame: 1, 2, 3, 4 and 5 years ]
  4. MACE [ Time Frame: 1, 2, 3, 4 and 5 years ]
    Combined endpoint as cardiac death, acute myocardial infarction or new revascularisation of the study vessel

  5. Stent thrombosis [ Time Frame: Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years ]
    Stent thrombosis according to the Academic Research Consortium definitions

  6. Device success rate [ Time Frame: intraoperative ]
    The frequency of a successful implantation with residual stenosis <20% of the study stent in all stenoses scheduled to be treated



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study.

Exclusion Criteria:

  • Age < 18 years
  • The patient does not wish to participate
  • The patient is not able to consent to randomization (eg intubated patients)
  • The patient do not live in West Denmark
  • The patient do not speak Danish
  • The patient is already included in this study
  • The patient is already participating in other stent studies
  • Life expectancy <1 year
  • Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor
  • Allergic to everolimus or biolimus
  • Only implanted BMS
  • Only performed POBA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093845


Locations
Layout table for location information
Denmark
Aarhus University Hospital
Skejby, Aarhus N, Denmark, 8200
Aarhus University Hospital Aalborg
Aalborg, Denmark, 9000
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Aarhus University Hospital Skejby
Boston Scientific Corporation
Biosensors Europe SA
Investigators
Layout table for investigator information
Principal Investigator: Michael Maeng, MD Aarhus University Hospital, Skejby, Aarhus N
Study Chair: Evald H Christiansen, MD Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael Mæng, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT02093845     History of Changes
Other Study ID Numbers: 1-10-72-3-14
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Keywords provided by Michael Mæng, Aarhus University Hospital Skejby:
Percutaneous coronary intervention
DES
Angina pectoris
Stent
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Pathologic Processes
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents