SORT OUT X - Combo Stent Versus ORSIRO Stent

Aarhus University Hospital Skejby

Status: Active, not recruiting

Conditions: Coronary Heart Disease; Angina Pectoris; Myocardial Infarction

Treatments: Device: ORSIRO; Device: COMBO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03216733

1-10-72-38-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,148 participants in 2 patient groups

COMBO

Experimental group

Description:

PCI with COMBO stent

Treatment:

Device: COMBO

ORSIRO

Active Comparator group

Description:

PCI with ORSIRO stent

Treatment:

Device: ORSIRO