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

Primary Purpose

Coronary Artery Disease

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PCI with BioMatrix Alpha™ stent
PCI with Combo™ stent
Sponsored by
Phillip Freeman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug eluting stent, Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Skejby
  • Odense Unversity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combo

BioMatrix Alpha

Arm Description

PCI with COMBO stent

PCI with BioMatrix Alpha stent

Outcomes

Primary Outcome Measures

Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
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)
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

Individual components of the primary end point comprise the secondary end points
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
Number of participants with Myocardial Infarction
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
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
Cardiac and non-cardiac
Target Vessel Revascularization due to clincal symptoms
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
Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
Number of patients with Patient-related composite end point
All death, all MI (including procedure related MI) or any revascularisation

Full Information

First Posted
May 10, 2019
Last Updated
April 25, 2023
Sponsor
Phillip Freeman
Collaborators
Aarhus University Hospital, Odense University Hospital, OrbusNeich, Biosensors International
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1. Study Identification

Unique Protocol Identification Number
NCT03952273
Brief Title
Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent
Acronym
SORTOUTXI
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
March 19, 2023 (Actual)
Study Completion Date
November 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Phillip Freeman
Collaborators
Aarhus University Hospital, Odense University Hospital, OrbusNeich, Biosensors International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug eluting stent, Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combo
Arm Type
Active Comparator
Arm Description
PCI with COMBO stent
Arm Title
BioMatrix Alpha
Arm Type
Active Comparator
Arm Description
PCI with BioMatrix Alpha stent
Intervention Type
Combination Product
Intervention Name(s)
PCI with BioMatrix Alpha™ stent
Other Intervention Name(s)
Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Intervention Description
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Intervention Type
Combination Product
Intervention Name(s)
PCI with Combo™ stent
Other Intervention Name(s)
Combined sirolimus eluting and endothelial progenitor cell Combo™ stent
Intervention Description
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Primary Outcome Measure Information:
Title
Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
Description
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.
Time Frame
Within 12 months
Title
Target Lesion Revascularisation (TLR)
Description
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.
Time Frame
Within 12 months
Secondary Outcome Measure Information:
Title
Individual components of the primary end point comprise the secondary end points
Description
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.
Time Frame
Clinical follow-up will be continued through 5 years
Title
Number of participants with Cardiac Death
Time Frame
Through 5 years
Title
Number of participants with Myocardial Infarction
Description
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.
Time Frame
Through 5 years
Title
Target Lesion Revascularization due to clincal symptoms
Description
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.
Time Frame
Through 5 years
Title
Number of patients with all cause mortality
Description
Cardiac and non-cardiac
Time Frame
Through 5 years
Title
Target Vessel Revascularization due to clincal symptoms
Description
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.
Time Frame
Through 5 years
Title
Number of patients with stent thrombosis
Description
Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
Time Frame
Through 5 years
Title
Number of patients with Patient-related composite end point
Description
All death, all MI (including procedure related MI) or any revascularisation
Time Frame
Through 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Freemann, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Odense Unversity Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only shared with collaborators

Learn more about this trial

Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

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