Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent (SORTOUTXI)

Phillip Freeman

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Treatments: Combination Product: PCI with BioMatrix Alpha™ stent; Combination Product: PCI with Combo™ stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03952273

Sort Out XI

Details and patient eligibility

About

SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.

Full 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

Enrollment: 3,141 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,141 participants in 2 patient groups

Combo

Active Comparator group

Description:

PCI with COMBO stent

Treatment:

Combination Product: PCI with Combo™ stent

BioMatrix Alpha

Active Comparator group

Description:

PCI with BioMatrix Alpha stent

Treatment:

Combination Product: PCI with BioMatrix Alpha™ stent