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SORT OUT X - Combo Stent Versus ORSIRO Stent (SORT OUT X)

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ClinicalTrials.gov Identifier: NCT03216733
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Biotronik SE & Co. KG
OrbusNeich
Information provided by (Responsible Party):
Lars Jakobsen, Aarhus University Hospital Skejby

Brief Summary:
The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of unselected patients with ischemic heart disease, using registry detection of clinically driven events.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Angina Pectoris Myocardial Infarction Device: COMBO Device: ORSIRO Not Applicable

Detailed Description:
Randomized Clinical Comparison of a Combined Sirolimus Eluting and endothelial progenitor cell COMBO Stent with a Sirolimus-eluting OSIRO stent in Patients Treated with Percutaneous Coronary Intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparison of a Combined Sirolimus Eluting and Endothelial Progenitor Cell COMBO Stent With a Sirolimus-eluting OSIRO Stent in Patients Treated With Percutaneous Coronary Intervention - The SORT-OUT X Study
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: COMBO
PCI with COMBO stent
Device: COMBO
PCI with COMBO stent
Other Name: Combined Sirolimus eluting and endothelial progenitor cell stent

Active Comparator: ORSIRO
PCI with ORSIRO stent
Device: ORSIRO
PCI with ORSIRO stent
Other Name: Sirolimus-eluting stent




Primary Outcome Measures :
  1. Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization [ Time Frame: Within 12 months ]

    Analysing the Kaplan-Meier method. Hazard ratios between groups will be calculated using a Cox proportional hazard model and the primary endpoint in the two per protocol treated groups will be compared with an upper one-sided 95% confidence interval.

    Patients treated with the OsiroTM stent will be used as the reference group


  2. Target Lesion Revascularisation (TLR) [ Time Frame: Within 12 months ]
    Repeat/new revascularization (PCI or CABG) within the stent or within a 5-mm border proximal or distal to the stent. (Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90). TLR will be clinically driven.


Secondary Outcome Measures :
  1. Individual components of the primary end point comprise the secondary end points [ Time Frame: Clinical follow-up will be continued through 5 years ]
    cardiac death; MI; clinically indicated TLR; all death (cardiac and noncardiac) and target vessel revascularisation (TVR); definite, probable, possible, and overall stent thrombosis according to the Academic Research Consortium definition (22); and a patient-related composite end point (all death, all MI (including procedure related MI), or any revascularization). For continuous variables, the difference between the treatment groups will be evaluated using Wilcoxon's rank-sum test. For discrete variables, the differences will be given as numbers and in percentages and will be analyzed using Fisher's exact test. Two-sided test will be used, and a pvalue of 0.05 considered significant.

  2. Cardiac death [ Time Frame: Through 5 years ]
  3. MI [ Time Frame: Through 5 years ]

    The acute MI diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of MI" (23), which has been adapted by Academy Research Consortium (22).

    In cases of updates of the definition of MI, the latest definition will be used.


  4. Clinically indicated TLR [ Time Frame: Through 5 years ]
    Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90.

  5. All death [ Time Frame: Through 5 years ]
    Cardiac and noncardiac

  6. TVR [ Time Frame: Through 5 years ]
    Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90.

  7. Stent thrombosis [ Time Frame: Through 5 years ]
    Definite, probable, possible and overall according to the Academic Research Consortium definition (22)

  8. Patient-related composite end point [ Time Frame: Through 5 years ]
    All death, all MI (including procedure related MI) or any revascularisation



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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 Rigshospitalet or one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.
  • The patients will be treated in accordance with the criteria applicable at the individual sites.
  • The investigators plan to include 3,140 patients.

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 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 sirolimus

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): NCT03216733


Contacts
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Contact: Lars Jakobsesn, MD 2280 7644 helbar@rm.dk
Contact: Evald H Christiansen, MD 6165 5176 evald.christiansen@dadlnet.dk

Locations
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Denmark
Aalborg University Hospital, Department of Cardiology Recruiting
Aalborg, Denmark, 9100
Contact: Svend E Jensen, MD       svend.eggert.jensen@rn.dk   
Aarhus University Hospital, Skejby Recruiting
Aarhus N, Denmark, 8200
Contact: Lars Jakobsen, MD    2280 7644    helbar@rm.dk   
Contact: Evald H Christiansen, MD    6165 5176    evald.christiansen@dadlnet.dk   
Rigshospitalet, Hjertecentret Not yet recruiting
København, Denmark, 2100
Contact: Jens F Lassen, MD       jens.flensted.lassen@rh.regionh.dk   
Contact: Thomas Engstrøm, MD       thomas.engstroem@rh.regionh.dk   
Odense Unversity Hospital, Department of Cardiology Recruiting
Odense C, Denmark, 5000
Contact: Lisette O Jensen, MD       okkels@dadlnet.dk   
Sponsors and Collaborators
Aarhus University Hospital Skejby
Biotronik SE & Co. KG
OrbusNeich
Investigators
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Principal Investigator: Lars Jakobsen, MD Aarhus University Hospital Skejby

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lars Jakobsen, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT03216733     History of Changes
Other Study ID Numbers: 1-10-72-38-17
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lars Jakobsen, Aarhus University Hospital Skejby:
DES
Angina pectoris
Stent

Additional relevant MeSH terms:
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Infarction
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina Pectoris
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs