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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Angina Pectoris
• Interventions: Device: Drug eluting stent

• Registration Number: NCT01956448
• Lead Sponsor: Aarhus University Hospital Skejby

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-06-04
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-06
• Last Update Submitted: 2013-10-06
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug eluting stent (BioMatrix Flex)	Drug eluting stent	Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex)
Drug eluting stent (Resolute Integrity)	Drug eluting stent	Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)

Primary Outcome Measures

Name	Time	Method
Device-related combined endpoint	1,2,3 and 5 years	Device-related combined endpoint hierarchically: cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months.

Secondary Outcome Measures

Name	Time	Method
Procedure time	12 months
Amount of contrast	12 months
Device success rate	12 months
Procedure success rate	12 months
Fluoroscopy time	12 months
Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation	30 days
Target lesion revascularisation	1,2,3 and 5 years
Death and myocardial infarction	1 and 12 months
Stent thrombosis	1,2,3 and 5 years
Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion	2,3 and 5 years
Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations	1,2,3 and 5 years
All-cause death	10 years

Trial Locations

Locations (3)

Aarhus University Hospital; 🇩🇰 Skejby, Aarhus N, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark