Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03952273

Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Skejby, Aarhus, Denmark

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI with BioMatrix Alpha™ stent

Combination Product

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

PCI with Combo™ stent

Combination Product

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Phillip Freeman

Other

Collaborators

  • Aarhus University Hospital
  • Biosensors International
  • Odense University Hospital
  • OrbusNeich

Registry information

Official study 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.

Acronym: SORTOUTXI

Important dates

Study start
2019
Primary completion
2023
Study completion
2030
First posted
May 16, 2019
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.