Clinical trial NCT03952273: Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent
Official 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug eluting stent
Stent
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
name: OrbusNeich
name: Biosensors International
First posted: 2019-05-16
Enrollment: 3141
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: 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

Eligibility criteria: 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

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: Number of participants with Cardiac Death
timeFrame: Through 5 years
measure: Number of participants with Myocardial Infarction
timeFrame: Through 5 years
measure: Target Lesion Revascularization due to clincal symptoms
timeFrame: Through 5 years
measure: Number of patients with all cause mortality
timeFrame: Through 5 years
measure: Target Vessel Revascularization due to clincal symptoms
timeFrame: Through 5 years
measure: Number of patients with stent thrombosis
timeFrame: Through 5 years
measure: Number of patients with Patient-related composite end point
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Odense
country: Denmark
facility: Odense Unversity Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Phillip Freemann, MD
role: PRINCIPAL_INVESTIGATOR
References: