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Active, Not Recruiting

NCT Number: NCT03216733

SORT OUT X - Combo Stent Versus ORSIRO Stent

The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of unselected patients with ischemic heart disease, using registry detection of clinically driven events.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Heart Disease Angina Pectoris Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Department of Cardiology, Aalborg, Denmark

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About this study

Randomized Clinical Comparison of a Combined Sirolimus Eluting and endothelial progenitor cell COMBO Stent with a Sirolimus-eluting OSIRO 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 Rigshospitalet or one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.
  • The patients will be treated in accordance with the criteria applicable at the individual sites.
  • The investigators plan to include 3,140 patients.

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 this study
  • The patient is already participating in other stent studies
  • Life expectancy <1 year
  • Allergic to aspirin, clopidogrel, prasugrel or ticagrelor
  • Allergic to sirolimus

Treatment and study plan

COMBO

Device

PCI with COMBO stent

Other names: Combined Sirolimus eluting and endothelial progenitor cell stent

Orsiro

Device

PCI with ORSIRO stent

Other names: Sirolimus-eluting 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

    Analysing 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 OsiroTM 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. Cardiac death

    Time frame: Through 5 years

  3. MI

    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. Clinically indicated TLR

    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. All death

    Time frame: Through 5 years

    Cardiac and noncardiac

  6. TVR

    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. Stent thrombosis

    Time frame: Through 5 years

    Definite, probable, possible and overall according to the Academic Research Consortium definition (22)

  8. 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

Aarhus University Hospital Skejby

Other

Collaborators

  • Biotronik SE & Co. KG
  • OrbusNeich

Registry information

Official study title

Randomized Clinical Comparison of a Combined Sirolimus Eluting and Endothelial Progenitor Cell COMBO Stent With a Sirolimus-eluting OSIRO Stent in Patients Treated With Percutaneous Coronary Intervention - The SORT-OUT X Study

Acronym: SORT OUT X

Important dates

Study start
2017
Primary completion
2018
Study completion
2028
First posted
Jul 13, 2017
Registry last updated
Nov 28, 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.

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