Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

Coronary Artery Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952273
• Other study ID #: Sort Out XI
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: November 30, 2030

Study information

• Verified date: April 2023
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3141
• Est. completion date: November 30, 2030
• Est. primary completion date: March 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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
• PCI with Combo™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus
Denmark	Odense Unversity Hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
Phillip Freeman	Aarhus University Hospital, Biosensors International, Odense University Hospital, OrbusNeich

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Number of participants with Cardiac Death		Through 5 years
Secondary	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
Secondary	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
Secondary	Number of patients with all cause mortality	Cardiac and non-cardiac	Through 5 years
Secondary	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
Secondary	Number of patients with stent thrombosis	Definite, probable, possible and overall according to the Academic Research Consortium definition (22)	Through 5 years
Secondary	Number of patients with Patient-related composite end point	All death, all MI (including procedure related MI) or any revascularisation	Through 5 years