SORT OUT X - Combo Stent Versus ORSIRO Stent (SORT OUT X)
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|ClinicalTrials.gov Identifier: NCT03216733|
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease Angina Pectoris Myocardial Infarction||Device: COMBO Device: ORSIRO||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||December 31, 2028|
PCI with COMBO stent
PCI with COMBO stent
Other Name: Combined Sirolimus eluting and endothelial progenitor cell stent
Active Comparator: ORSIRO
PCI with ORSIRO stent
PCI with ORSIRO stent
Other Name: Sirolimus-eluting stent
- 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
- 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.
- 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.
- Cardiac death [ Time Frame: Through 5 years ]
- 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.
- 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.
- All death [ Time Frame: Through 5 years ]Cardiac and noncardiac
- 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.
- Stent thrombosis [ Time Frame: Through 5 years ]Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
- Patient-related composite end point [ Time Frame: Through 5 years ]All death, all MI (including procedure related MI) or any revascularisation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216733
|Contact: Lars Jakobsesn, MD||2280 firstname.lastname@example.org|
|Contact: Evald H Christiansen, MD||6165 email@example.com|
|Aalborg University Hospital, Department of Cardiology||Recruiting|
|Aalborg, Denmark, 9100|
|Contact: Svend E Jensen, MD firstname.lastname@example.org|
|Aarhus University Hospital, Skejby||Recruiting|
|Aarhus N, Denmark, 8200|
|Contact: Lars Jakobsen, MD 2280 7644 email@example.com|
|Contact: Evald H Christiansen, MD 6165 5176 firstname.lastname@example.org|
|Rigshospitalet, Hjertecentret||Not yet recruiting|
|København, Denmark, 2100|
|Contact: Jens F Lassen, MD email@example.com|
|Contact: Thomas Engstrøm, MD firstname.lastname@example.org|
|Odense Unversity Hospital, Department of Cardiology||Recruiting|
|Odense C, Denmark, 5000|
|Contact: Lisette O Jensen, MD email@example.com|
|Principal Investigator:||Lars Jakobsen, MD||Aarhus University Hospital Skejby|