Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Combination Product: PCI with BioMatrix Alpha™ stent; Combination Product: PCI with Combo™ stent

• Registration Number: NCT03952273
• Lead Sponsor: Phillip Freeman

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 Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Study Start: 2019-08-14
• Primary Completion: 2023-03-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26
• Study Completion: 2030-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BioMatrix Alpha	PCI with BioMatrix Alpha™ stent	PCI with BioMatrix Alpha stent
Combo	PCI with Combo™ stent	PCI with COMBO stent

Primary Outcome Measures

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

Name	Time	Method
Target Vessel Revascularization due to clincal symptoms	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.
Individual components of the primary end point comprise the secondary end points	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	Through 5 years
Target Lesion Revascularization due to clincal symptoms	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	Through 5 years	Cardiac and non-cardiac
Number of participants with Myocardial Infarction	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.
Number of patients with stent thrombosis	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	Through 5 years	All death, all MI (including procedure related MI) or any revascularisation

Trial Locations

Locations (2)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark

Odense Unversity Hospital; 🇩🇰 Odense, Denmark