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Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent (SORTOUTXI)

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ClinicalTrials.gov Identifier: NCT03952273
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
Aarhus University Hospital
Odense University Hospital
OrbusNeich
Biosensors International
Information provided by (Responsible Party):
Phillip Freeman, Aalborg University Hospital

Brief Summary:
SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Combination Product: PCI with BioMatrix Alpha™ stent Combination Product: PCI with Combo™ stent Not Applicable

Detailed Description:
Randomized clinical comparison of the Sirolimus eluting and endothelial progenitor cell Combo™ stent and the Biolimus eluting absorbable polymer coated BioMatrix Alpha™ 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 the Combined Sirolimus Eluting and Endothelial Progenitor Cell Combo™ Stent and the Biolimus Eluting Absorbable Polymer Coated BioMatrix Alpha™ Stent in Patients Treated With Percutaneous Coronary Intervention.
Estimated Study Start Date : May 30, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2030

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Active Comparator: Combo
PCI with COMBO stent
Combination Product: PCI with Combo™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Other Name: Combined sirolimus eluting and endothelial progenitor cell Combo™ stent

Active Comparator: BioMatrix Alpha
PCI with BioMatrix Alpha stent
Combination Product: PCI with BioMatrix Alpha™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Other Name: Biolimus eluting absorbable polymer coated BioMatrix Alpha™ 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 ]
    The primary endpoint will be analyzed using 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 ComboTM 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. Number of participants with Cardiac Death [ Time Frame: Through 5 years ]
  3. Number of participants with Myocardial Infarction [ 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. Target Lesion Revascularization due to clincal symptoms [ 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. Number of patients with all cause mortality [ Time Frame: Through 5 years ]
    Cardiac and non-cardiac

  6. Target Vessel Revascularization due to clincal symptoms [ 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. Number of patients with stent thrombosis [ Time Frame: Through 5 years ]
    Definite, probable, possible and overall according to the Academic Research Consortium definition (22)

  8. Number of patients with 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 one of the three heart centers in Aarhus, Odense 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 speak Danish
  • The patient is already included in the SORT OUT XI study
  • Life expectancy <1 year
  • Allergic to study related treatment

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): NCT03952273


Contacts
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Contact: Phillip Freemann, MD +4597664457 p.freeman@rn.dk
Contact: Leif Thuesen, MD +4597664465 leif.thuesen@rn.dk

Locations
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Denmark
Aarhus University Hospital, Skejby Not yet recruiting
Aarhus, Denmark, 8200
Contact: Evald H Christiansen, MD       evald.christiansen@dadlnet.dk   
Odense Unversity Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Lisette O Jensen, MD       okkels@dadlnet.dk   
Sponsors and Collaborators
Phillip Freeman
Aarhus University Hospital
Odense University Hospital
OrbusNeich
Biosensors International
Investigators
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Principal Investigator: Phillip Freemann, MD Aalborg University Hospital

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Responsible Party: Phillip Freeman, Principal Investigator, MD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03952273     History of Changes
Other Study ID Numbers: Sort Out XI
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only shared with collaborators

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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 Phillip Freeman, Aalborg University Hospital:
Drug eluting stent
Stent

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs