SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® (SO VI)

Aarhus University Hospital Skejby

Status: Completed

Conditions: Coronary Artery Disease; Angina Pectoris

Treatments: Device: Drug eluting stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01956448

M-20110037

Details and patient eligibility

About

To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.

Full description

SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of atherosclerotic coronary artery lesions.

Primary Endpoint:

Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).

Secondary Endpoints:

Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).

Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death

Enrollment: 2,800 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent.

Exclusion criteria

• life expectancy of less than one year
• an allergy to aspirin, clopidogrel, ticagrelor, prasugrel, sirolimus, or biolimus
• participation in another randomized trial
• inability to provide written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,800 participants in 2 patient groups

Drug eluting stent (BioMatrix Flex)

Experimental group

Description:

Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex)

Treatment:

Device: Drug eluting stent

Drug eluting stent (Resolute Integrity)

Experimental group

Description:

Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)

Treatment:

Device: Drug eluting stent