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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Combination product: PCI with Combo™ stent; Combination product: PCI with BioMatrix Alpha™ stent

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: Interventional
• Enrollment (Actual): 3141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital, Skejby
  • Odense, Denmark, 5000
    • Odense Unversity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 12 months
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.	Within 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Clinical follow-up will be continued through 5 years
Number of participants with Cardiac Death		Through 5 years
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.	Through 5 years
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.	Through 5 years
Number of patients with all cause mortality	Cardiac and non-cardiac	Through 5 years
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.	Through 5 years
Number of patients with stent thrombosis	Definite, probable, possible and overall according to the Academic Research Consortium definition (22)	Through 5 years
Number of patients with Patient-related composite end point	All death, all MI (including procedure related MI) or any revascularisation	Through 5 years

Collaborators and Investigators

• Sponsor: Phillip Freeman
• Collaborators: Odense University Hospital; Aarhus University Hospital; Biosensors International; OrbusNeich
• Investigators: Principal Investigator: Phillip Freemann, MD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): March 19, 2023
• Study Completion (Anticipated): November 30, 2030

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Stent; Drug eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: Sort Out XI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only shared with collaborators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No