Clinical trial NCT03216733: SORT OUT X - Combo Stent Versus ORSIRO Stent
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Angina Pectoris
Myocardial Infarction
Keywords: DES
Angina pectoris
Stent
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
name: OrbusNeich
First posted: 2017-07-13
Enrollment: 3148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
timeFrame: Within 12 months
measure: Target Lesion Revascularisation (TLR)
timeFrame: Within 12 months
Secondary outcomes:
measure: Individual components of the primary end point comprise the secondary end points
timeFrame: Clinical follow-up will be continued through 5 years
measure: Cardiac death
timeFrame: Through 5 years
measure: MI
timeFrame: Through 5 years
measure: Clinically indicated TLR
timeFrame: Through 5 years
measure: All death
timeFrame: Through 5 years
measure: TVR
timeFrame: Through 5 years
measure: Stent thrombosis
timeFrame: Through 5 years
measure: Patient-related composite end point
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Department of Cardiology
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Skejby
city: København
country: Denmark
facility: Rigshospitalet, Hjertecentret
city: Odense C
country: Denmark
facility: Odense Unversity Hospital, Department of Cardiology
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Lars Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, Raungaard B, Ellert J, Villadsen AB, Kristensen SD, Ahlehoff O, Christensen MK, Terkelsen CJ, Erik Botker H, Aaroe J, Thim T, Thuesen L, Aziz A, Eftekhari A, Jensen RV, Stottrup NB, Rasmussen JG, Junker A, Jensen SE, Hansen HS, Jensen LO. Randomized Clinical Comparison of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent With the Sirolimus-Eluting Orsiro Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT X Trial. Circulation. 2021 Jun;143(22):2155-2165. doi: 10.1161/CIRCULATIONAHA.120.052766. Epub 2021 Apr 7.
citation: Jakobsen L, Christiansen EH, Maeng M, Kristensen SD, Botker HE, Terkelsen CJ, Madsen M, Raungaard B, Jensen SE, Christensen MK, Hansen HS, Jensen LO. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X trial. Am Heart J. 2018 Aug;202:49-53. doi: 10.1016/j.ahj.2018.04.019. Epub 2018 May 5.