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出境医 / 临床实验 / Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent (SORTOUTXI)

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

Study Description
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
Study Design
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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.
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : November 30, 2030
Arms and Interventions
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

Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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 Recruiting
Aarhus, Denmark, 8200
Contact: Evald H Christiansen, MD       evald.christiansen@dadlnet.dk   
Odense Unversity Hospital 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
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE August 14, 2019
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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.
  • Number of participants with Cardiac Death [ Time Frame: Through 5 years ]
  • 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.
  • 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.
  • Number of patients with all cause mortality [ Time Frame: Through 5 years ]
    Cardiac and non-cardiac
  • 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.
  • Number of patients with stent thrombosis [ Time Frame: Through 5 years ]
    Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • 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.
  • Cardiac death [ Time Frame: Through 5 years ]
  • 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.
  • 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.
  • All death [ Time Frame: Through 5 years ]
    Cardiac and non-cardiac
  • 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.
  • Stent thrombosis [ Time Frame: Through 5 years ]
    Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
  • Patient-related composite end point [ Time Frame: Through 5 years ]
    All death, all MI (including procedure related MI) or any revascularisation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent
Official Title  ICMJE 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.
Brief Summary SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Combo
    PCI with COMBO stent
    Intervention: Combination Product: PCI with Combo™ stent
  • Active Comparator: BioMatrix Alpha
    PCI with BioMatrix Alpha stent
    Intervention: Combination Product: PCI with BioMatrix Alpha™ stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
3140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2030
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Phillip Freemann, MD +4597664457 p.freeman@rn.dk
Contact: Leif Thuesen, MD +4597664465 leif.thuesen@rn.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952273
Other Study ID Numbers  ICMJE Sort Out XI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Only shared with collaborators
Responsible Party Phillip Freeman, Aalborg University Hospital
Study Sponsor  ICMJE Phillip Freeman
Collaborators  ICMJE
  • Aarhus University Hospital
  • Odense University Hospital
  • OrbusNeich
  • Biosensors International
Investigators  ICMJE
Principal Investigator: Phillip Freemann, MD Aalborg University Hospital
PRS Account Aalborg University Hospital
Verification Date April 2021

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

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